Nasal Implants and Systems and Methods of Use

ABSTRACT

Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools. A tool may include a hand-held implant delivery device that cuts, holds, moves, orients, inserts, or shapes an implant. An implant may be a biodegradable, longitudinal implant that may be oriented for implantation by an implant delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/339,220 filed Oct. 31, 2016, which is a divisional of U.S. patentapplication Ser. No. 14/192,365, filed Feb. 27, 2014, which claims thebenefit under 35 U.S.C. § 119 of U.S. Provisional Patent Application No.61/770,008 filed Feb. 27, 2013 and U.S. Provisional Patent ApplicationNo. 61/785,816 filed Mar. 14, 2013, the disclosures of which areincorporated herein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention pertains to implants for placing in a body, toolsfor delivering the implants, and systems and methods for using implantsand tools for placing in a body and more particularly to nasal implants,tools for delivering nasal implants, and systems and methods for usingsuch implants and tools.

BACKGROUND

The particular nasal anatomy of an individual may cause or contribute tovarious problems, such as cosmetic concerns, difficulty breathing, sleepapnea, or snoring, and impact an individual's health or reduce thequality of life. For example, the structure of an external or internalnasal valve may resist airflow from the nose to the lungs and prevent anindividual from getting sufficient oxygen to the blood.

U.S. Pat. Nos. 8,133,276, 7,780,730, and U.S. 2012/0109298 describeimplants that can be introduced into the nasal region of an individualusing non-surgical injection techniques for treating a nasal valve of anindividual.

There is a continued need for improvements to address problemsattributed to nasal anatomy that are easier to use, last longer, areless invasive, are less expensive to manufacture, work better and so on.

SUMMARY OF THE DISCLOSURE

Described herein are implants for placing in a body, tools fordelivering the implants, and systems and methods for using implants andtools for placing in a body and more particularly to nasal implants,tools for delivering nasal implants, and systems and methods for usingsuch implants and tools. These may be useful in minimally invasiveprocedures, including outpatient procedures, and may result in minimalpain and rapid recovery. These systems, assemblies and methods may beused, for example, in a doctor's office or clinic, and in some cases mayrequire only a suitable local anesthetic. These implants, assemblies,systems, and methods may be especially useful for supporting orrepairing nasal tissue, such as an internal nasal valve or an externalnasal valve. Some implants may provide a long-term solution for improvednasal function or nasal cosmesis: a semi-permanent implant that degradesover a long time period may provide short-term nasal tissue supportwhile the implant is intact and may initiate a body response (e.g. afibrotic response) that strengthens nasal tissues and provides long-termnasal tissue support. A nasal treatment system may employ a pre-shapedor shapeable nasal implant including a bioresorbable material thatprovides structural support of surrounding nasal tissue. The assembliesand systems may penetrate through a patient's nasal tissue and allowprecise positioning of an implant within a patient's nose.

One aspect of the invention provides a nasal implant delivery systemincluding a delivery device and an implant. In some embodiments, thesystem includes a grippable housing with an implant delivery conduithaving a piercing end configured to pierce a nasal tissue. In someembodiments, the conduit includes an interior orienting portion with across-sectional shape configured to orient an implant relative to theconduit. In some embodiments, the system includes a longitudinal implantincluding a resiliently deformable portion configured to have acontracted first shape and an expanded second shape. In some suchembodiments, the first shape comprises a non-circular cross-sectionconfigured to orient the implant relative to the conduit by the conduitorienting portion when the implant is in place in the conduit. In someembodiments, the second shape includes an expanded shape configured toanchor the implant to nasal tissue when the implant is in place in thenasal tissue.

In some embodiments, the delivery device is configured to hold theimplant near a distal end of the conduit when the implant is in theconduit. In some embodiments, the conduit is configured to hold theimplant near a distal end of the conduit when the implant is in theconduit. In some embodiments, the conduit includes a 14 gauge, a 16gauge, or an 18 gauge needle and the implant is configured to sit in theneedle. In some embodiments, the delivery tool includes a window alongits length configured to accept the implant into the conduit. In someembodiments, the delivery device is configured to hold the implant at aproximal side of a bevel on the distal end of the conduit when theimplant is in the conduit. In some embodiments, the conduitcross-sectional shape includes an ellipse. In some embodiments, theconduit and implant are configured to provide a friction fit between theconduit and the implant when the implant is in the conduit.

In some embodiments, the resiliently deformable portion includes tinesconfigured to have the contracted first shape and the expanded secondshape. In some embodiments, the resiliently deformable portion includestines at an end of the implant. In some embodiments, a length of theimplant includes a plurality of repeating features. In some embodiments,the implant includes a plurality of ribs with alternating raised regionsand depressed regions. In some embodiments, the implant includes a firstend feature and a second end feature different from the first endfeature. In some embodiments, the first end feature includes a roundedend. In some embodiments, the implant includes a biodegradable material.In some embodiments, the implant includes a biocompatible biodegradablepoly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA). In someembodiments, the implant is configured to provide an implant flexuralrigidity between 2.5 e⁻⁶, and 1.5e⁻⁵.

Some embodiments include a stylet having a proximal graspable portionand a distal pushing portion configured to fit in the conduit. In somesuch embodiments, the stylet is configured move the implant through theconduit and into the tissue when the implant and the pushing portion arein place in the conduit and the pushing portion is moved through theconduit.

Another aspect of the invention provides a biodegradable longitudinalimplant including a first end including a resiliently deformable portionconfigured to have a contracted first shape and an expanded secondshape. In some embodiments, the first shape includes a non-circularcross-section configured to orient the implant relative to a deliveryconduit in a nasal implant delivery device. In some embodiments, thesecond shape includes an expanded shape configured to anchor the implantto nasal tissue when the implant is in place in the nasal tissue. Someembodiments include a second end including a second feature differentfrom the first feature. Some embodiments include a length therebetweenthe first end and the second end, including a plurality of repeatingfeatures. In some embodiments, the implant has an outer diameter lessthan 1.5 mm or less than 1.2 mm when in the contracted first shape.

In some embodiments, the implant is configured to provide an implantflexural rigidity between 2.5 e-6, and 1.5 e-5. In some embodiments, alength of the implant is less than 30 mm or less than 25 mm. In someembodiments, the resiliently deformable portion includes tines at an endof the implant. In some embodiments, the length includes a plurality ofrepeating features. In some embodiments, the length includes a pluralityof ribs with alternating raised regions and depressed regions. In someembodiments, the first end feature includes a rounded end. In someembodiments, the implant includes a biocompatible biodegradablepoly-L-lactic acid (PLLA) or poly-D-lactic acid (PDLA).

Another aspect of the invention provides system for placing an implantinto a nasal tissue of a patient including an assembly with a grippablehousing, a delivery conduit control mechanism, and an implant deliveryconduit. In some embodiments, the implant delivery conduit includes apiercing end configured to pierce a body tissue. In some embodiments,the conduit configured to hold an implant and to place the implant inthe body tissue. In some such embodiments, a movement of the deliveryconduit is controllable by the delivery conduit control mechanism. Insome embodiments, the delivery conduit control mechanism is configuredto move the delivery conduit away from the implant and towards thehousing without moving the implant.

Some embodiments include an implant pusher member configured to connectwith an end of the implant in the delivery conduit. In some suchembodiments, the implant pusher member is configured to control aposition of the implant when the implant is in place in the conduit. Insome embodiments, the delivery conduit control mechanism is furtherconfigured to move the conduit away from the implant pusher member.

Some embodiments include a first trigger member on an outside of thehousing. In some such embodiments, the first trigger member isconfigured to be activated by a finger of a user. In some suchembodiments, the activation moves the delivery conduit from a firstposition to a second position. In some such embodiments, the firsttrigger member is configured to move the delivery conduit into thehousing when the trigger member is activated. In some embodiments, thetrigger member is configured to be activated by a finger of a userpulling the trigger member. Some such embodiments include a handgripproximal to the first trigger member. In some such embodiments, thehandgrip is configured to be partially encompassed by a hand of the userwhen a finger of a user in place on the first trigger member. In someembodiments, the trigger arrangement and handgrip are further configuredto be usable by either a left-handed person or a right-handed person.Some embodiments include a second trigger member on a generally oppositeside from the first trigger member wherein the first trigger member andsecond trigger member are configured to be simultaneously pulled usingfingers from a hand of a user.

In some embodiments, the implant pusher member is configured to hold theimplant in place when the delivery conduit moves away from the implant.In some embodiments, a user controllable safety element is configured tohold the delivery conduit in an advanced position relative to thehousing.

Some embodiments further include an implant, e.g., including abiodegradable material. Some such embodiments include an implant pushermember wherein the implant pusher member and implant comprise matingends.

Some embodiments further include a support member connected with thegrippable housing and configured to abut a face of a patient, e.g., suchas when the delivery conduit is being retracted from the implant duringassembly use.

Another aspect of the invention provides a method of implanting animplant into a nasal tissue of a patient. Some embodiments include thesteps of loading an implant into a grippable housing, the housingincluding a delivery conduit control mechanism for controlling movementof a delivery conduit; attaching an implant delivery conduit with thehousing; advancing the implant through the conduit until the implant isclose to the distal end of the conduit; and piercing a nasal tissue withthe piercing end of the implant delivery conduit by moving the implantdelivery conduit through the nasal tissue; retracting the deliveryconduit from the implant and into the grippable housing using thedelivery conduit control mechanism to thereby leave the implant in placein the nasal tissue; and removing the implant delivery conduit from thepatient. In some embodiments, movement of the conduit is controllable bythe delivery conduit control mechanism.

Some embodiments include the step of releasing a user-controlled safetymechanism to thereby allow delivery conduit movement; and advancing theimplant further to the end of the conduit. Some embodiments include thestep of apposing the proximal end of the implant with an implant pushermember to thereby prevent movement of the implant relative to thedelivery conduit during the retracting the delivery conduit step. Insome embodiments, the housing is connected with a support member, themethod further includes the step of contacting support member with aface of a patient to thereby hold the housing in place on the face ofthe patient during the retracting the delivery step.

Another aspect of the invention provides a method of deliver an implantto a nasal tissue. Some embodiments include the steps of placing ahollow delivery conduit holding a resiliently deformable implant havinga first shape into a nasal tissue; and removing the hollow deliveryconduit away from the implant to thereby change the implant into asecond shape.

Another aspect of the invention includes a system for shaping an implantin a tissue in a body including a grippable housing including a deliveryconduit control mechanism, an implant delivery conduit, and an energydelivery element. Some embodiments include a grippable housing includinga delivery conduit control mechanism configured to control a deliveryconduit movement. Some embodiments include an implant delivery conduitwith a piercing end, the conduit connected with the delivery conduitcontrol mechanism and configured to pierce a body tissue with thepiercing end and place an implant in the tissue. Some embodimentsinclude an energy delivery element configured to deliver energy to theimplant when the implant and energy delivery element are in place in thetissue. Some embodiments include an energy source for delivering energyto the energy delivery element. Some embodiments include an energysource controller configured to control the energy delivered to theenergy delivery device from the energy source.

Some embodiments further include an energy-responsive implant disposedwithin the implant delivery conduit and configured to change from afirst shape to a second shape in response to an energy delivered fromthe energy delivery element. In some such embodiments, theenergy-responsive implant is configured to change from a first shape toa second shape by conforming to a shape of a structure in the bodytissue. In some embodiments, the energy-responsive implant comprises aheat-responsive biodegradable material. In some embodiments, theenergy-responsive implant includes at least one of poly-L-lactic acid(PLLA) or poly-D-lactic acid (PDLA). In some embodiments, theenergy-responsive implant includes an internal cavity configured toaccept the energy delivery element. In some embodiments, the energydelivery element is configured to deliver heat to the implant. In someembodiments the delivery conduit control mechanism is configured to movethe implant delivery conduit away from the energy-responsive implant tothereby place the implant in contact with nasal tissue.

Some embodiments further include an indicator configured to indicate areadiness of an energy source to deliver energy to the energy deliveryelement.

In some embodiments, the energy delivery element includes a flexiblematerial configured to conform to a shape of the implant. In someembodiments, the energy delivery element includes a resistive wireconfigured to fit inside the implant. In some embodiments, the energydelivery element is configured to at least partially wrap around animplant when the element is in use. In some embodiments, the energydelivery element further includes a ribbon.

Some embodiments include an insulating material configured to separatethe energy delivery element from the nasal tissue when the energydelivery element is in use to deliver energy to an implant.

In some embodiments, the implant delivery conduit is configured to atleast partially retract inside the grippable housing. In some suchembodiments, the energy delivery element is configured to travel fromthe grippable housing along an outside of the implant delivery conduitwhen the conduit is in a partially retracted position in the housing. Insome such embodiments, the implant delivery conduit is furtherconfigured to travel past the piercing end of the implant deliveryconduit and to thereby at least partially surround the implant. In someother embodiments, the energy delivery element further includes aclasping element configured to hold the energy delivery device to anoutside of the implant delivery conduit. In some other embodiments, theenergy delivery element further includes an insulating materialconfigured to separate the energy delivery element from the tissue whenthe energy delivery element is in use for delivering energy to theimplant.

Some embodiments include an energy delivery control mechanism connectedwith the housing and configured to move the energy delivery elementrelative to the body tissue or relative to an implant. In some suchembodiments, the energy delivery control mechanism is further configuredto move the energy delivery element relative to the housing. Some suchembodiments include a pulley mechanism configured to pull the energydelivery element into the housing. Some embodiments include a userinterface element on an outside of the housing configured to control anaction of the energy delivery control mechanism to thereby control theenergy delivery element in response to a user.

In some embodiments, the implant delivery conduit is configured to holdan implant within 10 mm of the piercing end during implant placement inthe tissue.

Another aspect of the invention provides a method of changing a shape ofa nose. Such a method may include the steps of inserting anenergy-responsive implant having a first shape into a nasal tissue;inserting an energy delivery element into the nasal tissue; deliveringenergy from the energy delivery element to the energy-responsive implantto thereby increase a flexibility of the energy-responsive implant;shaping the energy-responsive implant into a second shape; removingenergy from the energy-responsive implant to thereby hold it in thesecond shape; removing the energy delivery element from the nasal tissueapposing the energy-responsive implant having the second shape to anasal tissue; and applying a force from the energy-responsive implant tothe nasal tissue to thereby change the shape of the nose.

In some embodiments, the step of shaping the implant into a second shapeincludes conforming the implant to a shape of a portion of the nasaltissue. Some embodiments include the step of applying a force to theportion of the nasal tissue, e.g., to create a desired shape whereinshaping the implant includes conforming the implant to the desired shapeof the portion of the nasal tissue. In some embodiments, the step ofchanging a shape of the nose includes changing the shape of a nasalvalve.

Another aspect of the invention provides method of shaping a nasalimplant in a nasal tissue. The method may include the steps ofimplanting an energy-responsive implant having a first shape into anasal tissue; inserting an energy delivery element into an individual'snose; delivering energy from the energy delivery element to the implantto thereby increase a flexibility of the implant; shaping the implant toa second shape; and removing energy from the implant to thereby hold theimplant in the second shape.

In some embodiments, the shaping step includes conforming the implant toa shape in the body. In some embodiments, the removing energy stepincludes decreasing a flexibility of the implant. In some embodiments,the delivering energy step includes heating the implant. In some suchembodiments, delivering energy includes heating an implant materialabove the material glass transition temperature (Tg). Some embodimentsinclude the step of moving the energy delivery element into contact withthe implant prior to the delivering energy from the energy deliveryelement step. In some embodiments, the step of inserting an energydelivery element includes inserting an energy delivery element connectedwith a housing, the housing including a monitoring element, the methodfurther including monitoring at least one of an intensity of the energyfrom the energy delivery element, a temperature of the implant, and atemperature of the nasal tissue. In some embodiments, the monitoringstep includes using an open control loop process in the monitoringelement. In some embodiments, the monitoring step includes using closedcontrol loop process in the monitoring element.

Some embodiments further include the step of placing the implant incontact with a nasal tissue prior to the delivering energy from theenergy delivery element step. Some embodiments further include the stepof placing the implant in contact with a nasal tissue after thedelivering energy from the energy delivery element step. In someembodiments, the steps of delivering the energy and shaping the implantcomprises performing the steps simultaneously using a single tool. Someembodiments include repeating the delivering energy from the deliveryelement step, and the method further includes shaping the implant to athird shape. Some such embodiments include the step of removing energyfrom the implant to thereby hold the implant in the third shape.

Some embodiments include the step of implanting a second energyresponsive implant into a nasal tissue and repeating the deliveringenergy from the energy delivery element to the implant to therebyincrease a flexibility of the implant. Some such embodiments furtherinclude the step of shaping the implant to a second shape. Some suchembodiments further include the step of removing energy from the implantto thereby hold the implant in the second shape on the second implant.

In some embodiments, the energy delivery element includes a flexibleenergy delivery element disposed along a length of the implant, and theshaping step further includes simultaneously shaping the energy deliveryelement and shaping the implant to a second shape wherein deliveringenergy comprises delivering energy during the shaping step.

In some embodiments, the shaping step includes placing pressure on theimplant using a shaping instrument applied to at least one of the insideof the nose and the outside of the nose. In some embodiments, theshaping step includes placing pressure on the implant before and duringthe removing energy from the implant step. Some embodiments include thestep of leaving the implant partially in the needle during the shapingthe implant step. Some embodiments include repeating the deliveringenergy from the energy delivery element to the implant after theremoving step, and the method further includes the step shaping theimplant into a third shape.

In some embodiments, implanting further includes the steps of insertinga tip of the needle into the nose, the needle enclosing the implant andan implant pusher member; moving the needle, implant and implant pushermember through nasal tissue; retracting the needle proximally relativeto both the implant pusher member and the implant; and retracting theimplant pusher member away from the implant. Some such embodimentsfurther include the steps of moving the energy delivery element relativeto the implant after the moving the needle, implant and implant pushermember step; activating the energy delivery element; verifying atemperature of the energy delivery element; warming the implant;alerting the user when a set period of time has passed; shaping theimplant; removing the energy source from the implant; maintaining apressure on the implant to maintain an implant shape during the removingstep; removing the pressure from the implant; verifying the shape of theimplant; and removing the heating element from the implant withoutdisturbing the position of the implant. Some embodiments include thestep of maintaining the implant pusher member in place during theremoving the energy delivery element step. Some such embodiments includethe step of placing a shaping utensil in the nasal tissue and shapingincludes shaping using the shaping utensil. Some embodiments include thestep of verifying the shape of the implant after the shaping step.

Another aspect of the invention provides another method of shaping animplant in a nasal tissue, e.g., by heating the delivery conduit. Someembodiments include the steps of placing an implant delivery conduitencompassing an implant in the nasal tissue, wherein the implantcomprises a first shape; heating a portion of the delivery conduit tothereby heat the implant; and after the heating step, shaping theimplant into a second shape.

Some embodiments further include the step of retracting the implantdelivery conduit from the nasal tissue and from the implant to therebyplace the implant in contact with the nasal tissue after the shapingstep. In some embodiments, the implant delivery conduit includes aneedle generally concentric with and external to a cannula and thecannula includes an energy delivery element, the method further includesthe step of partially retracting the needle away from the implant beforethe heating a portion of the delivery conduit step. Some suchembodiments include the step of partially retracting the cannula beforethe shaping the implant step.

In some embodiments in which the implant delivery conduit includes abeveled needle, the method further includes heating the nasal tissue inthe vicinity of the delivery conduit with the heated delivery conduit.In some embodiments in which the implant delivery conduit includes aheated internal portion, the method further includes insulating thenasal tissue from the heated internal portion. In some embodiments, theheating step includes heating the implant to a temperature at or abovethe glass transition temperature (Tg) of an implant material. In someembodiments, the heating step includes the step of heating the implantabove body temperature but below the glass transition temperature (Tg)of an implant material.

Another aspect of the invention includes system for shaping an implantin a tissue in a body including a first grippable housing including animplant delivery conduit control mechanism; a second grippable housingincluding an energy delivery element control mechanism; and an energydelivery element. In some embodiments, the first grippable housingincludes an implant delivery conduit control mechanism configured toconnect with and move an implant delivery conduit relative to anenergy-responsive implant, and the grippable housing configured toreceive the implant delivery conduit and connectable with a joiningelement. In some embodiments, an implant delivery conduit is connectedwith the joining element and configured to hold an implant. Someembodiments include a second grippable housing including an energydelivery element control mechanism configured to connect with and movethe energy delivery element relative to the implant, and furtherconfigured to deliver energy to the energy delivery element, the secondhousing connectable with a joining element. Some embodiments include ajoining element connectable with the energy delivery element, the firstgrippable housing, and the second grippable housing. Some embodimentsinclude an energy delivery element configured to delivery energy to anenergy-responsive implant when the element and implant are in place. Insome embodiments, the connector is configured to connect with only oneof the first housing or the second housing at any given time.

Some embodiments include an energy responsive implant. Some embodimentsinclude a power source connected with the second grippable housing.

Yet another aspect of the invention provides a method of shaping a nasalimplant including at least partially encapsulating the implant with aflexible energy delivery device and delivering energy from the deliverydevice to the implant. Some embodiments include the steps of placing anenergy-responsive implant into a nasal tissue; at least partiallyencapsulating the implant with a flexible energy delivery elementconfigured to deliver energy to the implant; delivering energy from theenergy delivery element to the implant; and after the delivering step,shaping the implant into a desired shape.

In some embodiments, the flexible energy delivery element includes aflat strip, and the step of at least partially encapsulating includesplacing the flat strip along an outside of the implant. In someembodiments, the implant includes an internal hollow region, and thestep of at least partially encapsulating includes placing a resistivematerial inside the hollow region. In some embodiments, the step of atleast partially encapsulating includes placing a resistive wire insidethe internal hollow region, wherein the resistive wire configured todeliver heat to the implant. Some embodiments include an insulationelement and the method further includes the step of insulating nasaltissue from energy coming from at least one of the implant and theenergy delivery element. Some embodiments include the step of removingthe flexible energy delivery element from the nasal region.

Yet another aspect of the invention provides a method of shaping a nasalimplant in a nasal tissue, including inserting an energy deliveryconduit holding an implant into a nasal tissue and retracting theconduit to expose the implant to an outside of the conduit, anddelivering energy to the implant. The method may include the steps ofinserting a energy delivery conduit into a nasal tissue, the conduitholding an energy-responsive implant having a first shape, the conduithaving an energy delivery element disposed along an outside surface;retracting the conduit relative to the implant and relative to theenergy delivery element to thereby expose a portion of theenergy-responsive implant on an outside the conduit; placing the energydelivery element in proximity to the energy-responsive implant whereinthe conduit holds a portion of the implant; delivering energy from theenergy delivery element to the energy responsive implant to therebyincrease an implant flexibility; applying a force to the implant tothereby change the implant from a first shape to a second shape; andremoving energy from the implant to thereby hold it in the second shape.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1J show nasal tissue and various embodiments of implants forimplanting in nasal tissue according to the disclosure.

FIGS. 2A and 2B show different views of embodiment of an implantdelivery device for implanting a nasal implant into nasal tissue.

FIGS. 3A and 3B show different views of another embodiment of an implantdelivery device for implanting a nasal implant into nasal tissue.

FIGS. 4A and 4B show different views of another embodiment of an implantdelivery device for implanting a nasal implant into nasal tissue.

FIGS. 5A and 5B show different views of another embodiment of an implantdelivery device for implanting a nasal implant into nasal tissue.

FIGS. 6A and 6B show views of another embodiment of an implant deliverydevice for implanting a nasal implant into nasal tissue.

FIGS. 6C-6E show embodiments of implants that may be implanted such asby using the implant delivery device shown in FIGS. 6A and 6B.

FIGS. 7A-7C show how an implant delivery device is loaded with animplant, advanced to deliver an implant to a nasal tissue, and retractedfrom the tissue according to some embodiments.

FIGS. 8A-8C show how another implant delivery device is loaded with animplant, advanced to deliver an implant to a nasal tissue, and retractedfrom the tissue according to some embodiments.

FIGS. 9A-9C show how yet another implant delivery device is loaded withan implant, advanced to deliver an implant to a nasal tissue, andretracted from the tissue according to some embodiments.

FIGS. 10A-10J show embodiments of nasal implants and various implantfeatures.

FIGS. 10K-10N show cross-sectional views of various embodiments of nasalimplants.

FIG. 11 shows an embodiment of an implant delivery device for implantinga nasal implant into nasal tissue.

FIGS. 12A and 12B show different views of yet another embodiment of animplant delivery device for implanting a nasal implant into nasaltissue.

FIG. 12C shows another view of an embodiment of an implant deliverydevice.

FIGS. 13A-13C show different views of yet another embodiment of animplant delivery device for implanting a nasal implant into nasaltissue.

FIG. 14 shows a longitudinal cross-section view of another embodiment ofan implant delivery device.

FIGS. 15A-15C show various embodiments of handle grips of implantdelivery devices.

FIG. 16 shows another embodiment of an implant delivery device with adifferent handle grip.

FIG. 17 shows an embodiment of implant delivery device with a contourgrip.

FIG. 18 shows an embodiment of an implant delivery device with anothertype of handle grip.

FIG. 19 shows an embodiment of an implant delivery device with anothertype of handle grip.

FIG. 20 shows an embodiment of an implant delivery device with anothertype of handle grip.

FIG. 21 shows an embodiment of an implant delivery device with anothertype of handle grip.

FIG. 22 shows a portion of an embodiment of an implant delivery systemfor shaping an implant in a tissue in a body.

FIGS. 23A-23N show a method of shaping a nasal implant in a tissue usingan implant delivery device such as the one shown in FIG. 22 according toone aspect of the disclosure.

FIGS. 24A-24E show another embodiment of a system using energy forshaping an implant in a tissue in a body.

FIGS. 25A-25C show another embodiment of a system using energy forshaping an implant in a tissue in a body.

FIGS. 26A-26D show another embodiment of a system using energy forshaping an implant in a tissue in a body.

FIGS. 27A-27G show another embodiment of a system using energy forshaping an implant in a tissue in a body.

FIG. 28 shows an embodiment of a heating device and battery that can beused with a system using energy for shaping an implant in a tissue in abody, such as the system shown in FIGS. 27A-27G.

FIG. 29 shows an embodiment of an assembly with a support member usefulfor holding an implant delivery device in place during use.

FIG. 30 shows another view of an assembly with a support member usefulfor holding an implant delivery device in place during use.

FIG. 31 shows another view of an assembly with a support member usefulfor holding an implant delivery device in place during use.

FIGS. 32A-32D show different views of another embodiment of a nasalimplant system that may be useful for holding an implant in position ina tissue during needle retraction.

FIGS. 33A-33C show different views of another embodiment of a nasalimplant system that may be useful for holding an implant in position ina tissue during needle retraction.

FIGS. 34A-34C show different views of another embodiment of a nasalimplant system that may be useful for holding or pushing an implant inposition in a tissue during needle retraction.

FIGS. 35A-35C show different views of another embodiment of a nasalimplant system that may be useful for holding or pushing an implant inposition in a tissue during needle retraction.

FIGS. 36A-36F show different views of another embodiment of a nasalimplant system for holding or pushing an implant in position in a tissueand for holding an implant in an expanded configuration.

FIGS. 37A-37C show different views of another embodiment of a nasalimplant system useful for delivering a hollow implant to a nasal tissue.

FIG. 38 shows a sheet of implants connected by bridges.

FIGS. 39A-39D show an embodiment of a delivery tool for separating animplant from a sheet of implants, such as the sheet shown in FIG. 38,and for delivering the implant to a nasal tissue.

FIGS. 40A-40C show another embodiment of a delivery tool for separatingan implant from a sheet of implants, such as the sheet shown in FIG. 38,using a pusher and for delivering the implant to a nasal tissue.

FIGS. 41A-41D show another embodiment of a delivery tool for separatingan implant from a sheet of implants, such as the sheet shown in FIG. 38,for shearing the implant, shaving the outer surface of the implant, fordelivering the implant to a nasal tissue.

FIG. 42 shows an embodiment of an adjustable delivery tool adjustableuseful for handling different sizes of implants.

FIGS. 43A-43E show an embodiment of a delivery tool with a spring loadedclip for storing a multiple implants or a sheet of implants.

FIGS. 44A-44F show another embodiment of an implant delivery tool with arevolvable cylindrical housing for holding multiple implants.

FIGS. 45A-45D show another embodiment of an implant delivery tool forholding multiple implants end-to-end.

FIG. 46A is an end view of a sheet of nasal implants connected bybridges.

FIG. 46B is a perspective view of the sheet.

FIG. 47A is an end view of another sheet of nasal implants connected bybridges.

FIG. 47B is a perspective view of the sheet.

FIG. 48A is an end view of another sheet of nasal implants connected bybridges and openings that may allow for a needle and suture to passthrough.

FIG. 48B is a perspective view of the sheet.

FIG. 49A is a partial end view of another sheet of nasal implantsseparated by a large sheet section with holes.

FIG. 49B is a perspective view of the sheets.

FIG. 50A is a partial end view of another sheet of nasal implantsaligned in pairs.

FIG. 50B is a perspective view of the sheet.

FIG. 51A is a partial end view of another sheet of nasal implants havingrounded ends and connected by bridges with openings.

FIG. 51B shows a perspective view of the sheet.

FIGS. 52A-52H show details of another sheet of nasal implants connectedby bridges.

FIGS. 53A and 53B show an implantable sheet being cut.

FIGS. 54A-54C show results of flexural rigidity from a flexed implantrod.

FIGS. 55A and 55B show results from a 1000 cycle test using a testfixture.

FIGS. 56A and 56B show results from testing the implant migration aftermanually flexing tissue for 5 minutes.

FIG. 57 shows a table of material property test results of candidateimplants made into various shapes and sizes.

FIG. 58 shows a table of results from testing various material sampleswith heat for moldability and brittleness.

FIGS. 59A and 59B show different views of the anatomy of the noseincluding the external nasal valve and internal nasal valve.

FIGS. 60A and 60B show a collapsed nasal valve upon inhalation.

FIGS. 61A-61D show a delivery system with different views of a deliverytool (FIGS. 60A and 60B) and implants (FIGS. 60C and 60D) that may bedelivered using the delivery tool.

FIGS. 62A-62D show implants that may be formed as a long structure (FIG.63D).

FIG. 63C shows a detail view of the section indicated by “A” in FIG.62B.

FIGS. 63A-63C show embodiments of different hand-held delivery toolswith different types of hand-grips.

FIGS. 64A and 64B show a delivery tool with the needle advance (FIG.64A) and retracted (FIG. 64B) according to one aspect of the invention.

FIG. 65 shows examples of nasal implants implanted in nasal tissueaccording to one aspect of the invention.

FIGS. 66A-66C show examples of nasal implants implanted in nasal tissueaccording to one aspect of the invention. FIGS. 66A and 66B showplacement of implants in a “spreader” region.

FIGS. 67A-67C show an embodiment of a method for placing one or moreimplants in nasal tissue.

FIGS. 68A-68D show steps in preparing an implanting an implant in anose.

FIG. 69 shows subjective interpretation of nasal obstruction symptomsafter implanting implants in a pilot study after 6 months and 12 months,compared with pre-implantation symptoms.

DETAILED DESCRIPTION

Various regions of airway tissue can impact airflow to the lungs. Onemajor impact on airflow is from airflow resistance from the nose. Thehighest resistance structures in the nose may be the narrowest regions,such as the external nasal valve and the internal nasal valve. Duringnormal inspiration, nasal valve cartilage around these valves preventsor reduces valve collapse and helps maintains airway patency.Incompetent internal and/or external valves can collapse and obstructairflow during inhalation. Problems with the nasal septum, nasalturbinates, lateral cartilage, or other structures due to, for example,aging, poorly formed or weak cartilage, surgery (e.g. rhinoplasty,septoplasty) and/or trauma can lead to nasal valve problems and impactairflow.

Surgical treatments (e.g. submucosal resection of turbinates,septoplasty) have been used in the past to reduce the size of theturbinates or correct deviated septum or to repair the nasal wall inorder to improve the nasal valves and airflow. These surgical treatmentsare invasive, uncomfortable and require significant time to recuperate.Furthermore, they do not readily address problems with the lateralcartilage wall. The lateral cartilage wall has been repaired, forexample, by cartilaginous graft techniques using additional material(cartilage) from the nose or ear. In addition to the above mentionedlimitations, these techniques are expensive (e.g. thousands of dollars),highly invasive, require a high level of surgical experience, have long,painful recovery times (e.g. 3 weeks of downtime), do not always workwell and require a second surgical invasion site (into the nasal area orear to obtain cartilage). Invasive nasal surgery is complicated by theongoing need to use the surgical site for breathing. Thus, invasivesurgical approaches are far from ideal. Non-surgical approaches fornasal valve collapse include strips or stent-like materials (e.g.“BreathRight”, Breathe with EEZ, Nozovent”) that are placed on or aroundthe nose. These temporary, suboptimal approaches suffer from limitedefficacy and poor cosmesis.

Provided herein are implants, assemblies, systems, and methods usingimplants, assemblies, and systems that may be used for supporting andrepairing a body tissue. These may be useful in minimally invasiveprocedures, including outpatient procedures, and may result in minimalpain and rapid recovery. These systems, assemblies and methods may beused, for example, in a doctor's office or clinic, and in some cases mayrequire only a suitable local anesthetic. These implants, assemblies,systems, and methods may be especially useful for supporting orrepairing nasal tissue, such as an internal nasal valve or an externalnasal valve. Some implants may provide a long-term solution for improvednasal function or nasal cosmesis: a semi-permanent implant that degradesover a long time period may provide short-term nasal tissue supportwhile the implant is intact and may initiate a body response (e.g. afibrotic response) that strengthens nasal tissues and provides long-termnasal tissue support. A nasal treatment system may employ a pre-shapedor shapeable nasal implant including a bioresorbable material thatprovides structural support of surrounding nasal tissue. The assembliesand systems may penetrate through a patient's nasal tissue and allowprecise positioning of an implant within a patient's nose.

FIG. 1A shows the underlying structural anatomy and tissues of a facewith the muscles and skin removed. Bones of the nose and the rest of theface are indicated. An implant may be placed apposed to, within orattached or connected to any of the nasal tissues or surroundingtissues. In some embodiments, an implant is placed within a nasaltissue. In some embodiments, an implant is partially within a nasaltissue and partially within a surrounding tissue (e.g., a maxilla).

One aspect of the invention provides a nasal implant for nasal valverepair. Such a nasal implant may be used to strengthen or otherwiserepair valves that previously may have been treated using a cartilagegrafting technique. FIGS. 1B and 1C show prior implants used forinternal valve repair. FIG. 1B shows a spreader graft implanted into apatient's nose. FIG. 1C shows an alar batten graft implanted into apatient's nose. FIG. 1D shows four implants according to one embodimentof the invention implanted into a patient's nose to strengthen the nasalvalves in these same regions. Any type of implant may be used, such asany of those described herein or in U.S. Pat. Nos. 8,133,276, 7,780,730,and U.S. 2012/0109298. A method for using an implant may include thesteps of moving the implant though the mucosa, passing the implantthrough the nasal region medial to the lateral cartilage, and passingthe implant along the maxilla. An implant may additionally, or instead,be placed for treating a spreader region, submucosally, between thelateral cartilage and septal cartilage. In some embodiments, theimplants are made of an absorbable material. They are implanted inpositions that support the lateral wall cartilage and help resist orreduce movement of the cartilage during inhalation, thereby keeping thepatient's airway open. As shown, the implants are positioned such thattheir distal most points are in close contact with the maxilla. Theimplant may be disposed between the maxilla and the overlying softtissue (as shown in FIGS. 1F and 1G). FIG. 1F shows internal anatomy ofa nose and a position (see oval in FIG. 1F) in which an implant can beplaced. Note that the implant crosses (or lies adjacent to) one regionthat is substantially maxillary bone and another region that issubstantially cartilage. FIG. 1G shows an implant in place in nasaltissue, such as in the position shown in FIG. 1F relative to nasal bone4830, the frontal process of the maxilla 4832, the lateral cartilage4834, the greater lateral cartilage 4836, the lesser alar 4838, andfibrofatty tissue 4840. Some of the nasal tissue has been cut away inFIG. 1F to illustrate the relationship of the implant relative to thenasal tissue in the region of the maxilla bone. In particular, theimplant is leveraged between the maxilla bone 4844 below the implant andthe soft tissue above the implant. Soft tissue above the bone (such asthe periosteum, muscle, dermis 4842, etc.) may be tightly apposed to thebone. The soft tissue and the bone may envelope the implant and therebyhold it in place. An implant held in this manner provides leverage toother portions of the implant (e.g. those running through or near thelateral cartilage) to hold the implant in place and to provide supportto the cartilage and to the nasal valve. This leverage may allow theimplant to support lateral cartilage from collapse. The implant may besubstantially prevented from rotating and/or from moving longitudinally.An implant may prevent inward movement of lateral cartilage uponinspiration, but cause no change in cosmesis.

Alternatively, the distal face of the implant may be simply placed incontact with the edge of the maxillary surface. In both cases, theproximal end of the implant may extend to a position under the lateralwall cartilage, as in a deep alar graft.

The implant may also be placed in the same position as the conventionalspreader graft shown in FIG. 1B, i.e., between the top rim of the septalcartilage and the lateral wall cartilage to increase the angle of thelateral cartilage as it extends from the base of the nose. FIG. 1H showsa view looking into a patient's nostrils before placement of implants.FIGS. 1I and 1J show two implants that have been placed endonasallythrough the mucosa to wedge between lateral cartilage and the septum ofthe nose to increase the internal nasal angle.

As indicated above, the nose is organized into a complex 3-dimensionalgeometry with a wide variety of tissue types in a relatively small area.The 3-dimensional geometry is important for these tissues (andassociated tissues not shown in these views) to carry out variousfunctions, such as getting air (especially oxygen) to the lungs, warmingthe air, humidifying the air, and smelling odors—both good and bad—fromfood and other items. A nasal implant placed in the nose should improve(or maintain) nasal function and/or improve (or maintain) nasalappearance without causing unacceptable side effects. As such, placingthe right implant into the right tissue in the complex 3-dimensionalstructure may provide these advantages. Controlling the short-term andlong-term effects of an implant on the nasal tissues may also influencenasal implant success. An implant optimally sized and optimally shapedto fit into the particular nasal tissue to have the desired effect mayprovide particular success. An implant that fits into or even conformsto the shape of a particular nasal tissue being treated (e.g. changed orsupported) may be especially beneficial in some cases. Provided hereinare implants, assemblies, systems, and methods using such implants,assemblies, and systems, that may be used to control the initialplacement of an implant into a tissue area of interest or provide animplant especially suitable for short-term or long-term success inimproving (or maintaining) nasal function and/or nasal appearance.

FIGS. 2A-2B, 3A-3B, 4A-4B, 5A-5B, and 6A-6E show simple nasal implantsystems and variations for inserting an implant into a nasal tissue.

FIGS. 2A-2B and FIGS. 3A-3B show a nasal implant system in use. FIG. 2A(perspective view) and FIG. 2B (longitudinal cross-sectional view) showa nasal implant system in preparation for, or in the process of movingthrough, nasal tissue for placing an implant in a nasal tissue. (Nasaltissue is not shown in this view). FIG. 3A (perspective view) and FIG.3B (longitudinal cross-sectional view) show the same nasal implantsystem as it appears after the implant was placed in the nasal tissue.The nasal implant system may include a delivery needle, a stylet, and animplant.

FIGS. 2A-2B show a system 150 including a hollow delivery needle 152 forplacing implant 104 into a nasal tissue. Hollow delivery needle 152 haspiercing end 162 for penetrating the tissue for placement. Hollow needle152 may be held or may be moved using needle knob 156, such as bypushing on needle knob 156 to insert needle 152 into a nasal tissue orpulling on knob 156 to remove needle 152 from nasal tissue and away froman implant. System 150 may include implant 104. Implant 104 may bepre-loaded into needle 152 prior to use by a physician or other user ormay be loaded by a physician or other user into needle 152 at the timeof treatment (e.g., at the time of a minimally invasive or non-invasiveprocedure). System 150 may also include a stylet 158 configured to fitinside needle 152. Stylet 158 may hold implant 104 inside hollow needle152 or may hold implant 104 in a first position relative to the nasaltissue, such as when needle 152 is retracted away from implant 104.Stylet 158 may push implant 104 inside needle 152 to adjust a positionof implant 104. For example, stylet 158 may push implant 104 toinitially place or to re-position it in needle 152, such as prior toneedle 152 and implant 104 being placed into nasal tissue. Stylet 158may push implant 104 into an implant insertion position such that distalend 168 of implant 104 is near piercing end 162 of needle 104. Inparticular, distal end 168 may be at the proximal side of the bevel onthe piercing end. Needle 156 is moved through nasal tissue to an implantlocation. The depth of insertion of the needle into tissue may beindicated by marks 164 visible to the physician or other user. Suchmarks may, for example, be in increments of 1 mm for up to 30 mm.Because the depth of the needle in the tissue is indicated by the marksand the needle will be retracted away from the implant, the marks mayprecisely indicate the depth to which the implant will be placed. Thephysician or other user may receive tactile feedback from body tissue todetermine when the needle is in place. For example, the physician orother user may “feel” the needle hitting a hard object (e.g., a bone) or“feel” a change in the way the needle behaves. Alternatively, if theneedle comprises a radiopaque material, the physician may “see” theposition of a needle using imaging equipment.

After moving needle 156 through nasal tissue to the implant location,but before the implant is released from the needle, stylet 158 may pushimplant 104 into an implant implantation position such that distal end168 of implant 104 may be at the distal-most side of the bevel on thepiercing end. The movement of the distal end of the implant from theproximal side of the bevel to the distal side of the bevel may bemovement between 0 mm and 10 mm, between 1 mm and 7 mm, or between 2 mmand 4 mm. Hollow delivery needle 152 holding an implant 104 may beplaced into nasal tissue.

FIGS. 3A-3B show the same nasal implant system as in FIGS. 2A-2B as itappears after the implant was placed in nasal tissue. Structures changedin position in FIGS. 3A-3B relative to FIGS. 2A-2B are indicated by theaddition of a lowercase letter (“a”, “b”, etc.) after the correspondingreference numeral (such as 152 a). In particular, after implant 104 wasin the desired nasal tissue location (but was still inside hollow needle152) with stylet 158 abutting proximal end 166 (e.g., the end nearestthe physician or other user) of implant 104, needle 152 b was retractedby moving (e.g., pulling) needle knob 156 b away from implant 104 toleave implant 104 in the tissue in the same location as it was in whileinside the needle. In the next step, stylet knob 160 and needle knob 156b can be pulled (either together, or separately), removing the styletand the needle from the tissue, leaving the implant in place in thetissue to improve (or maintain) nasal function and/or improve (ormaintain) nasal appearance.

In another embodiment, needle 152 may be held still relative to implant104. In this case, implant 104 may be pushed out of the needle by thepushing action of stylet 158 against the proximal end 166 of implant104. In yet another embodiment, implant 104 may be placed in the nasaltissue (e.g. removed from the needle) using both actions: retracting theneedle away from the implant as well as pushing the implant away fromthe needle with the stylet.

FIGS. 4A-4B show another embodiment of a nasal implant system forplacing an implant into a nasal tissue similar to the nasal implantsystem shown in FIGS. 2A-2B and FIGS. 3A-3B with different controlfeatures. Needle knob 176 a-176 b comprises an elongated knob and may begrasped or held by a hand of a user or a finger and a thumb to moveneedle 172, as described above, into and out of nasal tissue. See alsocross-sectional view 186. Stylet or pusher 178 may be grasped or held bya hand of a user (e.g. a different hand) or a finger and thumb of a userwhen the stylet is in place inside needle 172 to hold implant 104 inplace while retracting needle 172 to place implant 104 into nasaltissue.

FIGS. 5A-5B show another embodiment of a nasal implant system implantfor placing an implant into a nasal tissue similar to the nasal implantsystems shown in FIGS. 2A-2B and FIGS. 3A-3B and FIGS. 4A-4B but with acontoured needle and with different control features. Such a contouredneedle may be useful for placing a shaped (e.g. a contoured) implantinto a nasal tissue (e.g. for placing an implant into an area that ishard to reach with a straight needle or for contouring the implant intothe tissue to better support the tissue). A contoured implant may betterconform to a tissue shape to provide support. A pre-formed contouredimplant may be more effective at re-shaping a portion of a nasal tissuefrom a first shape to a second shape, such as by providing more force tothe tissue. A contoured implant may provide better support (e.g.compared with an implant with a circular cross-section). FIG. 5A alsoshows the elliptical cross-sections 181 of the implant and needle.

FIGS. 6A-6E show another embodiment of a nasal implant system similar tothe nasal implant systems described above. An implant and an inside of aneedle may comprise (matching) elliptical cross-sectional shapes.However, the implants shown in FIGS. 6C-6E are pre-formed to have acurvature. Some implants may comprise a resilient material. Someimplants may be temporarily deformed for a short time in a needle (e.g.a curved implant may be placed in a straight needle) in order for theneedle to place the implant into a nasal tissue. Some embodimentsprovide a method of placing an implant in a tissue, including the stepsof applying a force to an implant having a pre-delivery shape (or firstshape) in a needle to hold it in a delivery shape (or second shape);placing the needle and the implant having the delivery shape into anasal tissue; and removing the needle from the implant to thereby removethe force and allow the implant to return to its pre-delivery shape(first shape). The implant may include a soft barb to provide protectionfrom movement, as described in more detail below. The needle crosssection or shape provides for orientation of the implant.

Another aspect of the invention includes a system for placing an implantinto a nasal tissue of a patient. Such a system may include an assembly,including a grippable housing and a delivery conduit control mechanism,and a needle (or other implant delivery conduit such as a hollow implantdelivery conduit) with a piercing end configured to pierce a bodytissue, the conduit configured to hold an implant and to place theimplant in a body tissue wherein a movement of the delivery conduit iscontrollable by the delivery conduit control mechanism. Such a systemmay allow the implant to be unsheathed from the needle once in positionin the tissue. Such unsheathing may allow an implant to be placed withgreater precision and control into a specific nasal tissue region.

FIG. 7A shows a configuration of a nasal implant system 100 with anassembly 101 and a hollow delivery needle 102 (or other hollow deliveryconduit) for implanting an implant 104 into a nasal tissue. FIG. 7Ashows the implant being loaded into the needle. FIGS. 7B and 7C showother configurations of the same system during use for placing animplant in a nasal tissue. FIG. 7B shows an implant loaded in a needleand the needle advanced, just before needle retraction to place theimplant in position. FIG. 7C shows the needle retracted away from theimplant and the implant in position in the nasal tissue. A structure ina different position between related figures (e.g. between FIGS. 7A, 7B,and 7C) is indicated by the addition of a letter (“a”, “b”, etc.) afterthe corresponding reference numeral (such as 101 a, 101 b). FIG. 7Ashows loading an implant into the nasal implant assembly and moving theimplant distally near the distal end of the needle. FIG. 7B showsinserting the needle into nasal tissue and advancing the implantdistally to the distal end of the needle. FIG. 7C shows retracting theneedle and placing (releasing) the implant into the tissue.

FIG. 7A shows a hollow delivery needle with a proximal end (nearest thephysician or other user) and a distal end (nearest the patient), thedistal end having a piercing end 112 such that it can pierce and travelthrough nasal tissue to a desired implant location when a force isapplied to the needle. Needle 102 a is hollow and attached via a luerfitting 130 to a luer mating part (not visible in this view) of body 111of the assembly. Prior to being attached to the body 111, a nasalimplant was loaded into the proximal end of the needle. A system forplacing an implant in a nasal tissue may further have a stylet (or otherimplant pusher member) for positioning the implant. To move implant 104into an implant position in the needle (e.g., to the distal end of theneedle) the physician (or other user) moves the stylet control lever 114a from a proximal to a distal position, which moves the stylet againstthe proximal end of the implant and pushes the implant near the distalend of the needle. Compare the position of stylet control lever 114 a inFIG. 7A with the forward (distal) position of stylet control lever 114 bin FIG. 7B. The implant is placed at the base of the bevel (the shorterside of the bevel portion) of the piercing end 112 (distal end) of theneedle. In other embodiments, the implant may be placed partway alongthe bevel. Generally, the end of the implant may be at the base of thebevel, or less than 1 mm, less than 2 mm, less than 3 mm, or less than 6mm from the base of the bevel. The implant is now in a travel positionin needle 102 a and implant 104 to travel through nasal tissue to animplant position. Needle 102 also has a piercing end 112 on its distalend. Body 111 is held by a hand of a physician or other user to guideneedle 102 a, which holds implant 104, via the piercing end 112, throughbody tissue to the desired implant location in nasal tissue. In someembodiments, having an implant near the end of the needle to at leastpartially block the needle opening reduces or prevents tissue coring (inwhich tissue is cored or collected inside the needle). Preventing orminimizing coring reduces patient pain and recovery time. Placing theimplant at the base of the bevel without substantially protruding fromthe needle opening permits the beveled distal tip to perform its cuttingfunction as the needle is advanced into tissue.

After moving needle 102 a through nasal tissue to the implant location,but before the implant is released from the needle, the physician (orother user) moves the stylet control lever 114 a from a proximal to adistal position, which pushes implant 104 slightly further to the distalend of the needle (e.g. to the distal side of the bevel on the piercingend). This movement may be between 0 mm and 10 mm, between 1 mm and 7mm, or between 2 mm and 4 mm. This additional movement places theimplant close to or beyond the point to which the distal end of theneedle as inserted into nasal tissue.

The system may also include a needle control mechanism 108 a (e.g., adelivery conduit control mechanism) for controlling movement of needle102 a. Needle control mechanism 106 a retracts from a first position,shown in FIG. 7B, to a second position, needle control mechanism 106 b,shown in FIG. 7C, so that it retracts needle 102 a from a first positionshown in FIG. 7B, proximally away from implant 104, and into a secondposition in grippable housing 110, shown by needle 102 b in FIG. 7C.When the needle retracts, it leaves implant 104 in place in the nasaltissue in the desired location. The needle control mechanism may includea lever 108 a configured for use by a physician or other user to controlneedle movement. Lever 108 a may be moved from a first position (shownin FIG. 7B) to a second position (see lever 108 b in FIG. 7C). A stylet(not visible in this view) may extend distally between the grippablehousing 110 and may be at least partially disposed inside the hollowneedle 102 a or 102 b. The stylet may connect with the proximal end ofthe implant and may control implant movement relative to the needle. Inparticular, the stylet may prevent the implant from moving proximallywhile the needle is being retracted. Instead, the stylet may keep theimplant in the desired location as the implant is unsheathed from theneedle (e.g., the needle is retracted away from the implant). In someembodiments, such unsheathing means that the needle, specifically thepiercing tip of the needle, which is designed to enter tissue andminimize tissue damage, is responsible for all tissue penetration. Animplant does not need to be pushed or forced into position against nasaltissue. Tissue damage, patient pain, and healing times may all bereduced.

Additionally, the control mechanism and the needle may move relative tothe housing; that is, the housing remains in its position while theneedle control mechanism and needle retract towards it or through it orpartially through it. In particular, the assembly is configured so thatthe housing and the stylet—and the implant—can be held steady by thephysician or other user while the needle moves so that the implant isplaced in the desired location in the nasal tissue.

In some embodiments, the assembly may allow the physician or other userto readjust the needle after it is in place in the tissue.

In some embodiments, an implant may be loaded in the distal end of theneedle. In some embodiments, a needle may be pre-loaded with an implant,such as on its own or as part of a kit, before use by a physician orother user. In some embodiments, an implant may be loaded into a needleby a physician or other user before performing a nasal implantprocedure, such as a non-invasive or minimally invasive procedure. Insome embodiments, an implant may be loaded into a stylet channel througha side port (e.g. in the assembly body).

In some embodiments a needle may (e.g., larger than 10 gauge, 10, 11,12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,30, 31, or 32 gauge, or smaller than 32 gauge). An implant may be sizedto fit (e.g., fit tightly inside the needle). In some embodiments usinga smaller needle may product less tissue damage. In some embodiments, asmaller needle may (better) fit into small areas of the nasal tissue(e.g., between the skin/mucosa and cartilage of the nose).

FIGS. 8A-8C show another embodiment of a system for placing an implantinto a nasal tissue of a patient, related to the embodiment of FIGS.7A-7C. FIG. 8A shows a configuration of a nasal implant system 130 withan assembly 131 and a hollow delivery needle 102 (or other hollowdelivery conduit) for implanting an implant 104 into a nasal tissue.FIG. 8A shows the implant being loaded into the needle. FIGS. 8B and 8Cshow other configurations of the same system during use for placing animplant in a nasal tissue. FIG. 8B shows an implant loaded in a needleand the needle advanced, just before needle retraction to place theimplant in position. FIG. 8C shows the needle retracted away from theimplant and the implant in position in the nasal tissue. FIG. 8A showsloading an implant into the nasal implant assembly and moving the distalend of the implant near the distal end of the needle. FIG. 8B showsinserting the needle into nasal tissue and advancing the implantdistally to the distal end of the needle. FIG. 8C shows retracting theneedle and placing (releasing) the implant into the tissue. The detaileddescription of the implant loading, implant advancement to the distalend of the needle, placement of the needle and implant into nasaltissue, and retraction of the needle to place the implant into the nasaltissue and in contact with the nasal tissue is as described above forFIGS. 7A-7C. Changes relative to FIGS. 7A-7C include the shape andorientation of stylet control lever 144 a, 144 b and the shape andorientation of needle control mechanism 137 a, b.

FIGS. 9A-9C a system for placing an implant into a nasal tissue of apatient. FIGS. 9A-9C show another embodiment of a system for placing animplant into a nasal tissue of a patient, related to the embodiment ofFIGS. 7A-7C and FIGS. 8A-8C. FIG. 9A shows a configuration of a nasalimplant system 130 with an assembly 131 and a hollow delivery needle 102(or other hollow delivery conduit) for implanting an implant 104 into anasal tissue. FIG. 9A shows the implant being loaded into the needle.FIGS. 9B and 9C show other configurations of the same system during usefor placing an implant in a nasal tissue. FIG. 9B shows an implantloaded in a needle and the needle advanced, just before needleretraction to place the implant in position. FIG. 9C shows the needleretracted away from the implant and the implant in position in the nasaltissue. FIG. 9A shows loading an implant into the nasal implant assemblyand moving the distal end of the implant near the distal end of theneedle. FIG. 9B shows the configuration of the system while insertingthe needle into nasal tissue and advancing the implant distally to thedistal end of the needle. FIG. 8C shows the configuration of the systemwhile retracting the needle and placing (releasing) the implant into thetissue. The detailed description of the implant loading, implantadvancement to the distal end of the needle, placement of the needle andimplant into nasal tissue, and retraction of the needle to place theimplant into the nasal tissue and in contact with the nasal tissue is asdescribed above for FIGS. 7A-7C. Changes relative to FIGS. 7A-7C includethe shape and orientation of stylet control lever 184 a, 184 b and theshape and orientation of needle control mechanism 177 a, b.

As indicated above, at different times, implant 104 may be moved insideassembly 101 or moved inside needle 102 or may be held in place insideassembly 101 or inside needle 102. An end of implant 104 may be held bythe stylet. Needle 102 may be further internally configured to holdimplant 104 such as by tight fit with an implant. The tight fit may be“just right”—a friction fit sufficiently tight to hold the implantinside the needle, but loose enough to allow the force from a stylet orother pusher to hold the implant in place during needle retraction toplace the implant into nasal tissue. In such embodiments, a deliveryneedle can be retracted away from an implant in order to place theimplant into the nasal tissue without the need for a mechanism to holdthe implant or a mechanism or cutting tool to release the implant fromthe needle. A “just right” friction fit may also be helpful for holdingthe implant in the needle, such as in a kit.

FIGS. 10A-10J show various embodiments of implants. Any of theseimplants may be used with any of the systems, assemblies, and devicesand with any of the methods described herein or an implant may be usedwith other system, assembly, or device described elsewhere.

Such implants may be useful for placing in a body tissue, such as nasaltissue. One aspect of the invention provides a generally longitudinalresilient implant comprising: a first end, a second end and a lengththerebetween, the implant comprising a surface feature along the length.In some embodiments, an implant is configured to provide an implantflexural rigidity between 2.5 e-6, and 1.5 e-5. In some embodiments, animplant is configured to provide an implant flexural rigidity between2.5 e-6, and 1.5 e-5 after being in contact with a body tissue for atleast 3 months, for at least 6 months, for at least 9 months, or for atleast one year. Some embodiments of an implant include one or aplurality of surface features (such as, e.g., a fin, a notch, a rib, ora scallop. Some embodiments of an implant comprise a resorbable feature(such as, e.g. PLLA-PDLA in a ratio from 90:10 to 50:50. Someembodiments include an implant with a bend, with an angle greater than 0degrees and less than 45 degrees, less than 35 degrees, less than 25degrees, or less than 15 degrees. Some embodiments include an implantless than 30 mm, less than 25 mm, less than 20 mm, or less than 15 mm.Some embodiments include an implant with a diameter (e.g. an outerdiameter) configured to form a tight fit within a 16 gauge needle. Someembodiments have an outer diameter less than 1.5 mm, less than 1.2 mm,less than 1.0 mm or between 0.8 and 1.2 mm. In some embodiments, animplant comprises a color that is not readily visible through skin (e.g.skin-tone, tan, brown, etc.). In some embodiments, an implant comprisesa radiopaque material. An implant may preserve its shape; may be strong,yet flexible; it may be similar to cartilage in such properties.

Another aspect of the invention includes a generally longitudinalimplant having a first end, a second end, and a length there between,the first end comprising an end feature. In some embodiments, the secondend comprises an end feature. In some embodiments, the first end featureand the second end features may comprise the same configuration. In someembodiments the first end feature and the second end features maycomprise different configurations. In some embodiments, an end featureis configured to mate with a pusher tool. In some embodiments, an endfeature comprises an ellipse. In some embodiments, an end featurecomprises an expansion feature, such as tines or fins. An expansionfeature may be useful, when inserted into a nasal tissue, for preventingthe implant from moving, such as, for example, from moving into the pathor space left after a removal of a needle that placed the implant in thetissue. An expansion feature may be useful for anchoring the implant toa bone or to cartilage. In some embodiments, an implant with anelliptical distal end may allow seating of the implant against a bone atany angle.

An end feature may be useful for fixing an implant together with atissue. One or more than one surface features may be useful for fixingan implant together with a tissue.

Another aspect of the invention provides an adjustable implant (e.g.adjustable for an individual patient). In some embodiment, a shape of animplant is conformed in situ to a shape of a nasal tissue. In someembodiments, a particular length of an implant can be chosen based on anindividual's nasal structure size(s).

FIG. 10A shows an implant comprising scallops such as a series ofcircular segments or angular projections. Such scallops, segments orprojections may provide additional surface area (e.g. for tissueinteraction) to reduce or prevent implant movement (such as backing outof the implant into an incision or needle insertion site). Suchscallops, segments or projections may be used to provide an indicationof length and to provide stability during implant cutting.

FIG. 10B shows an implant comprising an elliptical first end and anelliptical second end. An elliptical end may provide greater surfacearea to rest against a tissue at any angle.

FIG. 10C shows an implant comprising an elliptical first end(semi-elliptical). An elliptical end may provide greater surface area torest against a tissue at any angle.

FIG. 10D shows an implant comprising a plurality of ribs and a conicalfirst end and a conical second end. An implant may include one rib ormore than one rib. Such ribs may include alternating raised regions anddepressed regions (valleys) with smooth transitions between the a riband a depression (valley). A conical end may provide greater surfacearea to rest against tissue at any angle when an implant is in place ina tissue. A rib(s) along the shaft may provide additional surface areafor the tissues to adhere. A valley of ribs may provide stability whencutting an implant.

FIG. 10E shows an implant comprising a plurality of fins and a conicalend (as described above). One or more than one fin may provideadditional surface area for tissue to adhere to the implant. A valley offins may provide stability during implant cutting.

FIG. 10F shows an implant with a first semi-elliptical end and a secondend with a concave end feature. A concave end feature may allow tissueto embed within the implant. A concave end feature may mate with acorresponding (e.g. elliptical) shape on an insertion tool (e.g. astylet, a pusher).

FIG. 10G shows an implant with a first semi elliptical end and aplurality of notches (e.g. along one side or one region of the implant).One or more than one notch may provide leverage to reduce or preventimplant movement (such as backing out of the implant into or through anincision or needle insertion site). One or more than one notch mayprovide stability during cutting and indication of implant length (e.g.for implant cutting).

FIG. 10H shows an implant with a first semi-elliptical end and a secondend with an expansion feature(s). A concave expansion feature may allowtissue to embed within the implant. A concave end feature may mate witha corresponding (e.g. elliptical) shape on an insertion tool (e.g. astylet, a pusher). The flared geometry may be compressed within aninsertion tool (e.g. needle) and expanded or allowed to expand afterbeing placed in tissue. Such an expansion feature may provide leverageto reduce or prevent implant movement (such as backing out of theimplant into or through an incision or needle insertion site).

FIG. 10I shows an implant with a first semi-elliptically shaped end anda second end with a plurality of tines. One or more than tine on animplant end may be compressed within the insertion tool (needle). Upondeployment into the tissue, the tine or tines may expand and provideleverage for the implant. Such an expansion feature may provide leverageto reduce or prevent implant movement (such as backing out of theimplant into or through an incision or needle insertion site).

FIG. 10J shows an implant with a first conical end and a second conicalend and a plurality of modified fins along the shaft. The modified finsshow a (continuous) progression from a shorter length to a longer lengthfrom a first region (which may a first end region) to a second region(which may be a second end region). Such modified fins may provideadditional surface area for the tissue to adhere. A valley of fins mayprovide stability when cutting an implant and may provide an indicationof implant length (e.g., for implant cutting).

A ribbed implant or an implant with a regular, repeating patterncomprising a biodegradable material may provide a controlled degradationpathway.

FIGS. 10K-10N show cross-sectional views of various embodiments of animplant.

FIG. 11 and FIGS. 12A-12C shows other systems for placing an implantinto a nasal tissue of a patient. Such systems may include an assemblycomprising a grippable housing and a delivery conduit control mechanism,and a needle (or other hollow implant delivery conduit) configured tohold an implant and to place the implant in the nasal tissue, the needlefurther having a piercing end to pierce body tissue for moving theneedle through the body tissue.

FIG. 11 shows another configuration of a nasal implant system 500 withan assembly 501 and a hollow delivery needle 102 (or other hollowdelivery conduit) for implanting an implant 104 into a nasal tissue.FIGS. 12A-12C show a similar nasal implant system 520 with a stylecontrol knob variation that can be used to push an implant into a needle(e.g. into a proximal end of a needle prior to attachment of the needleto the assembly. Nasal implant system 500 or nasal implant system 520may include an unsheathing option to thereby more precisely place animplant into a particular nasal tissue. Taken together, FIG. 11 andFIGS. 12A-12C, show the configuration of the system during steps inplacing an implant into a nasal tissue. FIG. 11 shows the nasal implantsystem with delivery needle 102 ready to place for placing an implantinto a nasal tissue (not shown). Referring to FIGS. 12A and 12B, implant104 has a proximal end (closest to the physician or other user; notreadily visible in this view) and a distal end 168. Implant 104 hadpreviously been loaded into the proximal end of delivery needle 102 andthe proximal end of delivery needle 102 connected with grippable housing510. Implant 104 had been distally advanced by being pushed throughneedle 102 with a stylet (e.g. rotation of implant control knob 508 by aphysician or other user) to sit close to piercing end 112 of needle 102under control of implant control knob 508, and held close to piercingend 112 of the needle. Delivery needle 102 with implant 104 held nearits piercing end 112 had then been placed in body tissue (e.g. nasaltissue) and advanced through body tissue (e.g. through nasal tissue orsurrounding tissue) to place piercing end 112 of needle 102 at adistal-most end of the desired implant location. Once the piercing end112 of needle 102 was in place, implant 104 had been further distallyadvanced to be placed at the very distal end of needle 102 (e.g. at thedistal end of the bevel). At this point, the implant is ready to beplaced into the nasal tissue and the implant can be unsheathed from theneedle. A user grabs or holds the hand grip 512. The user places a firstfinger on (the distal portion) of first trigger member 502 and a secondfinger on (the distal portion) of second trigger member 504. A userpresses safety button 514 to allow needle 102 movement. The user pullson the first trigger member and second trigger member to therebywithdraw the needle into grippable housing 510 and to unsheath implant104 in place in the tissue. Assembly 501 is then withdrawn from thenasal tissue, leaving the implant in place.

FIGS. 13A-13C show engineering views of one embodiment of a devicesimilar to that shown in FIG. 11 and FIGS. 12A-12C. FIGS. 14 and 15shows a side views and inner workings of an embodiment of an assemblysimilar to the assemblies shown in FIG. 11, FIGS. 12A-12C, and FIGS.13A-13C. FIGS. 14-21 show various embodiments of grippable housings,hand grips, and triggers, including a single trigger, a double trigger,a “pencil grip” embodiment and a pistol grip embodiment. In someembodiments, a double trigger and pistol grip are combined. In someembodiments, the assembly/handgrip is configured to allow a singleperson to perform various actions (e.g. inserting the needle and implantinto tissue, unlocking the needle safety, unsheathing theimplant/withdrawing the needle from the tissue, and withdrawing theassembly from the nasal tissue). In some embodiments, the assembly/gripis configured to be usable by either a right-handed or a left-handedperson (e.g., without making any changes to the assembly/handgrip). Insome embodiments, the assembly is configured to place the implant withno more than 10 N. In some embodiments, the assembly is configured toretract with no more than 10 N.

Another aspect of the invention provides systems, assemblies, andimplants and methods for shaping an implant in a tissue in the body.Shaping an implant in vivo may allow the shape of the implant to becustom fit (sized and shaped) to the nasal anatomy to better address thecondition that is being corrected by the implant. Shaping an implant invivo (e.g. to a non-linear shape) may also reduce tissue damage by, forexample, allowing a smaller needle to be used for implant insertion. Useof a custom shaped implant may provide an advantage such as providing alarger reshaping surface, providing an increased level of support to atissue in need of support, reducing the likelihood of extrusions (e.g.,the implant being pushed out of place), or reducing the likelihood ofthe explant being externally visible. Although a custom formed implantmay provide an advantage, there are a number of obstacles to generallyproviding an in vivo custom formed implant. One obstacle is how toprovide energy to an implant so that the implant becomes responsive tobeing shaped. Another obstacle is how to minimize tissue damage thatmight be due to a system or device used for shaping or deliveringenergy. Another obstacle is how to prevent nasal tissue from beingdamaged by an energy provided for shaping an implant. Another obstacleis how to remove any energy delivery elements or shaping devices whilepreventing or minimizing damage to nasal tissue. Another obstacle is howto reshape implant that is disposed inside a nasal tissue when theimplant is not readily accessible to a physician or other individual.Another obstacle is what to do if an implant is initially formed into anundesired shape.

An implant may be heated by external heating/conduction heating. Afterimplant insertion, heat is applied through conduction directly to thepatient's nose with a heater tool either from inside the nostril,outside the nostril, or both simultaneously. A heater tool may be usedto apply force to shape the implant. An implant may be heated byexternal heating/alternate heating in which heat is applied directly tothe patient's nose with a heater tool either from inside the nostril,outside the nostril, or both simultaneously. The source of heat may be,for example, ultrasonic or microwave. An implant may be heated with apre-heated cannula heater, as described below. After insertion theneedle tip is heated. This heats the implant and the local tissue toreduce cooling of the implant. The needle is removed and the implant isquickly shaped (freeform shaping). An implant may be heated by internalheating/cannula heater as described below. After insertion, the needleis retracted exposing a heater at the end of a cannula. This heats theimplant at the end of cannula. The heater is pulled off the implant asit is shaped. An integrated insertion tool and heater tool may be used;shaping can occur simultaneously with implantation. An implant may beheated with a flexible heater/ribbon heater as described below. Aflexible heater element encapsulates the implant. Both components areinserted together into the patient. After needle retraction, theflexible heater is heated and the implant shaped. The flexible heater isthen removed. The heater may be a flexible ribbon heater wrapped aroundthe implant. Insulation material may be present to protect internaltissue. The insertion tool and heater may be integrated together. Thismay allow for a local implant temperature well above a glass transitiontemperature, which may allow for simpler bending of the implant. Animplant may be heated using internal heating/flexible heater/coiled wireas described below. The flexible heating element may be located in thecenter of the implant. The heater can be a resistive heater or a thermalconductor. Both components may be inserted together into a patient.After needle retraction, the flexible heater may be heated and theimplant shaped.

Any form of energy that allows an implant to be shaped may be used (e.g.heat, microwave, ultrasonic). Any form of energy delivery to the implantthat allows or causes a change in the implant may be used. For example,energy may be delivered from outside the nose (such as, e.g., byconduction, or by ultrasonic waves or microwaves. Energy may deliveredfrom inside the nose, such as by a heater heating an end of an implant,a heater heating a side of an implant, a heating an inside of a nose. Asystem for shaping an implant in a tissue in a body includes a grippablehousing comprising a delivery conduit control mechanism; a hollowimplant delivery conduit with a piercing end, the conduit connected withand its movement controllable by the delivery conduit control mechanism,the conduit configured to hold an implant, pierce a body tissue with thepiercing end, and place the implant in the tissue; an energy deliveryelement configured to deliver energy to the implant when the implant andthe energy delivery element are in place in the tissue; an energy sourcefor delivering energy to the energy delivery element; and an energysource controller configured to control the energy delivered to theenergy delivery element from the energy source.

FIG. 22 shows a portion of a system 188 for shaping an implant in atissue in a body and FIGS. 23A-23C show steps in shaping a nasal implantin a nasal tissue using such a system. The system and method use aheating element between the implant and stylet and carried into thenasal tissue using a delivery needle. Similar to other needles andimplants described elsewhere in the disclosure, FIG. 22 shows implant104 disposed in a needle 102, as they would appear in position in atissue, ready for unsheathing of the implant by the needle to place theimplant in place in the tissue. Implant 104 comprises a heat responsivematerial (e.g., an energy responsive material), such that implant 104may become more flexible upon exposure to heat. FIG. 22 additionallyshows a heater 190 (an energy delivery element) between the stylet andthe implant and configured to provide heat to the implant. FIGS. 23A-23Nshow steps in inserting a heat responsive implant into a tissue, andchanging a shape of the implant. FIGS. 23A-23B show preparation steps.FIG. 23A shows a physician examining the nose to find the optimalposition for the implant, and applying anesthesia to the patient nearthe insertion site. The physician waits for the anesthesia to takeeffect and cleans the surface of the insertion site with an antisepticsolution. FIG. 23B shows the implantation tool is made ready, removingit from sterile packaging. FIGS. 23C-23I show insertion steps. FIG. 23Cshows the needle tip of the implantation tool is inserted into the noseof the patient by the physician. FIG. 23D shows the needle is carefullynavigated through the nasal tissue to ensure the path is in the correctposition. The depth of the needle is monitored via visual cuesintegrated on the outside shaft. The depth is dictated by location ofimplant to bone. The location of the implantation tool can still beslightly altered up, down, right, and left. FIG. 23E shows that once atthe correct depth and location, the needle is released and allowed tomove relative to the stylet and implant. FIG. 23F shows the needle isremoved from around the implant while the implant and stylet remainedfixed. FIG. 23G shows the implant remains inside of the nasal tissuewith the heating element interfacing with the implant. FIG. 23H showsthe heater is activated and allowed to reach the correct temperature.FIG. 23I shows the heater warms the implant to allow it to becomesoftened at the locations that need to be modified. FIGS. 23J-23N showimplant shaping. FIG. 23J shows that once the implant is moldable, theimplant is shaped by applying pressure with the shaping instrument. FIG.23K shows that the heater is turned off and the shape of the implant isset by allowing it to cool. FIG. 23L shows the shape of the implant isverified and additional heating and shaping are applied if needed. FIG.23M shows that with the stylet still engaged, the heating element isremoved from around the implant. FIG. 23N shows the stylet and theimplantation tool are removed from the patient. The custom shapedimplant remains in the nasal tissue. A method of shaping an implant in atissue may include the steps of placing an energy-response implanthaving a first shape into a nasal tissue; inserting an energy deliveryelement into an individual's nose; delivering energy from the energydelivering element to the implant to thereby increase a flexibility ofthe implant; shaping the implant into a second shape; and removingenergy from the implant to thereby hold the implant in the second shape.Using such system or method may allow an implant to conform to a bodytissue during shaping to provide a precise fit between an implant and abody tissue.

FIGS. 24A-24E shows another embodiment of a system 200 for shaping animplant using energy in a tissue in a body. FIG. 24A shows implant104(a) is disposed inside cannula heating element 198 a which in turn isdisposed inside needle 1196 a for the needle to deliver the cannulaheating element and the implant to a desired implant tissue location foran implant in a nasal tissue. After delivering the implant 104(a),cannula 198 a, and needle 196 b to the desired location, needle 196 a isretracted, as shown in FIG. 24C, unsheathing and leaving cannula 198 aand implant 104 a surrounded by cannula 198 a in the desired implanttissue location. After heating the implant but protecting nasal tissuefrom excess heat with insulation 202, cannula 198 b may be retracted,unsheathing and leaving heated (flexible) implant 104(a) in the desiredtissue location. Implant 104 b may be quickly shaped such as creatingimplant bend 206. Any external pressure (e.g., a tool pressed against anoutside of the nose, or an internal pressure (e.g., a tool pressedagainst an inside of a nose) may be used to custom shape the implant tothe nasal tissue.

In other embodiments, the needle may remain in position around thecannula during the heating steps. In other embodiments, the needle andcannula may comprise a single unit.

Steps in the method of using such a heating element may include: placinga hollow delivery conduit encompassing an implant in the nasal tissue,the implant having a first shape; heating a portion of the deliveryconduit to thereby heat the implant; after the heating step, shaping theimplant into a second shape; and retracting the conduit from the nasaltissue and from the implant to thereby place the implant in contact withthe nasal tissue. In some embodiments, the delivery conduit comprises aninternal portion (cannula) comprising insulation, and the method furthercomprising insulating the nasal tissue from the FIGS. 25A-25C showanother embodiment of a system 196 for shaping an implant using energyin a tissue in a body. The system is a central axis heater, configuredto deliver energy to an implant from an inside (center) of the implant.Energy responsive implant 198 has a hollow inside for accepting aheating element 204, which may be, for example, a rod or wire (e.g., aresistive wire, a thermally conductive rod). A resistive wire may allowan implant to be uniformly heated across its length. FIG. 25A shows asystem 196 during insertion into a nasal tissue with needle 102 aencompassing implant 198 a which in turn encompasses heating element204. (The system maintains the same configuration it had just prior tobeing inserted into the nasal tissue). As shown in FIG. 25B and asdescribed elsewhere, after insertion into a desired location in atissue, needle 102 b is retracted, unsheathing implant 198 a. The heateris activated until the implant is above Tg. Once above Tg, the implantis freely shaped. When the desired shape is achieved, the heater isdeactivated, allow the implant to cool below Tg (which may be less than,for example, 20 seconds). The heater element inside the heater elementis retracted while the back of the implant is held in place, as shown inFIG. 25C. The device is then retracted off the implant.

FIGS. 26A-26D show another embodiment of a system 224 for shaping animplant using energy in a tissue in a body, an integrated implanting andheating system with a central axis heater. The system integratesimplanting manipulation functions including needle retraction andheating functions including heating control and heater retraction into asingle housing. The system may be used with any implant or heat system,but may be especially useful with an implant system with a central axisheater for heating an implant, such as the one described in FIGS.25A-25C. FIG. 26A shows a perspective view and FIG. 26B shows across-section view of the system during implant delivery and beforeheating. FIG. 26C shows a section view of the system after retractingthe needle, but before heating and shaping are completed.

System 224 has a grippable housing 226. System 224 includes a heateron/off switch 236 for controlling the heat to the heater, a battery 234(e.g., energy source) for providing heat to the heater, and an LEDindicator light 238 to indicate when shaping can occur. System 224further includes a needle retraction button 228 which controls a sliderretraction mechanism 232 for connecting with and retracting the needleaway from the implant (desheathing) after the implant has been placed inposition in the tissue. System 224 further includes a heater retractionknob 230 connected with a pulley mechanism for retracting the heater.FIGS. 26A and 26B show the steps of inserting needle 102 to a desiredlocation in a nasal tissue; and unlocking needle retraction button 228a. FIG. 26C shows sliding needle retraction button 228 b to end oftravel to retract the needle and unsheath the implant. FIG. 26C alsoillustrates the steps of turning on heater on/off button 236, waitingfor LED indicator light 238 to turn on, indicating an implant is readyto be shaped from a first shape to a second shape by activating LEDindicator light 238, shaping implant into a second shape (not readilyseen in this view). FIG. 26D illustrates indicating that an implant issufficiently cooled (e.g. for an implant to hold its second shape),turning the heater retraction knob 230 to activate pulley retractionmechanism 240 and retracting heater 204 a out of implant 104. Finally,the assembly is removed from the nasal tissue.

FIGS. 27A-27G and FIG. 28 show another embodiment of a system 242 forshaping an implant using energy in a tissue in a body. The systemseparates implanting manipulation functions including needle retractionin a first housing, heating functions including heating control andheater retraction into a second housing and battery and heat controlinto a third housing. The system may be used with any implant or heatsystem, but may be especially useful with an implant system with acentral axis heater for heating an implant, such as the one described inFIGS. 25A-25C. FIG. 27A shows a perspective view and FIGS. 27B-27C showcross-sectional views of the needle control housing during use. FIGS.27D-27G show views of the heating and retraction device during use. FIG.28 shows a view of the battery and heat control housing.

System 242 has a first grippable housing 244 for controlling a needle.System 242 includes a first grippable housing 244 including a needleretraction button 228 which controls a slider retraction mechanism 232for connecting with and retracting the needle away from the implant(desheathing) after the implant has been placed in position in thetissue. System 242 includes a second grippable housing 246 including aheating and retracting device. System 242 includes third housing 248with a heater, a heater on/off switch 236 for controlling the heat tothe energy delivery element, a battery 234 for providing heat to theheater, and an LED indicator light 238 to indicate when shaping canoccur and when the implant has cooled sufficiently to hold its shape.

FIGS. 27A and 27B show steps of inserting needle 102 into nasal tissueand unlocking needle retraction button 228. FIG. 27C shows the steps ofsliding needle retraction button 228 to the end of travel and lockingthe needle retraction button. FIGS. 27C and 27D show removing theimplanting device from the heater and implant by twisting away andleaving energy responsive implant 198 attached to frame 250, includingelectrical contact 252 and threaded rod 254 for heater retraction. FIGS.27E and 27F show attaching heating and retraction device 246 a toimplant and heater 254. FIG. 27G shows a section view of an implant,heater, and retraction device with the heater retracted. It includes aone-direction, torque limiting threaded nut 241 and threaded rod 243connected to the heater. FIG. 28 shows the third housing with batterypack and heater controller 248 which can be attached by electrical wires239 to heating and retraction device 246. The third housing with batterypack and heater controller 248 is turned on using heater on/off button236. Once LED indicator light 238 turns on, implant 198 is shaped (suchas described elsewhere). After LED indicator light 238 turns off, aheater retraction knob on the second grippable housing-implant, heatingand retraction device 246 is turned to moved threaded rod 254 (shown inFIG. 27D) and retract heater out of the implant, as shown in FIG. 27F.

Any of the above described systems, assemblies, or methods may employ anenergy responsive implant. An energy source may raise the temperature ofthe implant above its glass transition temperature (Tg) so that it canbe shaped. When a material is above its Tg, it can be freely shaped.When the material temperature falls below the Tg, a material will holdits shape.

Any of the any of the above described systems, assemblies, or methodsmay use a heater tool to apply force to shape an implant. After shaping,the heating tool may be removed.

FIGS. 29-31 show an assembly 212 including a housing support member 216connected with grippable housing 214, with distal end 220 of supportmember configured to abut a patient's face during support member use.Such a housing support member may help hold assembly 212 in place (e.g.with minimal or essentially no movement) on the patient's face duringassembly use, such as while retracting the needle away from the implant;this keeps the implant in a desired implant location during needleretraction. In some embodiments, a housing support member may be anextension from the distal face of the assembly. In some embodiments ahousing support member may be slidable from the body of the deliverytool. In some embodiments, a housing support member may be spring loaded(e.g., comprising a rigid spring). In some embodiments, steps in using ahousing support member may include moving the housing support member tocontact a face of a patient, and locking the housing support member inplace. In some embodiments, steps in using a housing support member mayinclude moving the housing support member to contact a face of apatient, and sliding the housing support member proximally whileinserting the needle in the nasal tissue. In some embodiments, whereinthe grippable housing is connected with a housing support member, amethod of implanting an implant into a nasal tissue of a patient mayinclude the step of contacting the housing support member with a face ofa patient to thereby hold the housing in place on the face of thepatient during the retracting the delivery conduit from the implantstep. In order to place the implant (not visible in these figures) inthe tissue, a physician or other user may pull on trigger 222 to retractneedle 102 (e.g., retract needle 222 proximally) out of the tissue. Theneedle may be retracted relative to housing 214 and relative to housingsupport member 216. Housing 214 and housing support member 216 mayremain stationary (e.g., not move relative to one another) during theneedle retraction step.

An assembly for placing an implant in a nasal tissue, such as describedherein, may further comprise a support member connected with thehousing, the support member configured to abut a portion of a face of apatient when an assembly is in use on the patient.

FIGS. 32A-32D show a nasal implant system 3200 according to yet anotherembodiment of this invention. The system has a grippable housing 3204supporting an implant holder 3206. An implant 3202 such as, e.g., one ofthe implants described with respect to FIGS. 10A-10N above, is loadedinto the implant holder 3206, and a needle 3208 (such as, e.g., a 16 gbeveled hypodermic needle) is attached to the housing over the implantvia internal threads on needle actuator 3220.

A piston 3210 is slidably disposed within a bore 3212 of housing 3204,and a handle 3214 extends from piston 3210 to the underside of housing3204. A pusher 3216 extends from piston 3210 into implant holder 3206.Movement of handle 3214 toward a stationary handle 3218 advances thepusher 3216 through the implant holder 3206 to push the implant 3202distally into needle 3208. When the two handles meet, the distal end ofimplant 3202 is at the beveled opening of needle 3208, as shown in FIG.32D. In use, after the needle has been inserted into the desiredlocation in the patient's nose, the needle 3208 may be retracted fromthe implant 3202 by moving the needle actuator 3220 proximally to theposition shown in FIG. 32B. The pusher holds the implant in positionwhile the needle is retracted. In some embodiments, handle 3214 may bemoved further distally after insertion of the needle into nasal tissuebut before retraction of the needle to push the implant furtherdistally, e.g., to the distal end of the needle's beveled opening. Anopening 3222 in the distal portion of the housing enables the user toobserve and confirm needle retraction.

FIGS. 33A-33C show a nasal implant system 3300 according to anotherembodiment of this invention. The system has a housing 3304 supportingan implant holder (not shown). An implant 3302 such as, e.g., one of theimplants described with respect to FIGS. 10A-10N above, is loaded intothe implant holder, and a needle 3308 (such as, e.g., a 16 g beveledhypodermic needle) is attached to the housing over the implant viainternal threads on needle actuator 3320.

As shown in FIGS. 33A and 33B, an implant actuator 3310 extendsproximally from the housing. A pusher 3316 extends distally from theimplant actuator 3310 through the housing to the implant holder. Distalmovement of the implant actuator 3310 toward the housing moves thepusher toward the implant and the implant out of the implant holder andinto the needle to place the distal end of the implant at the beveledopening of the needle. Thereafter, proximal movement of the needleactuator 3320 retracts the needle from the implant while the pusherholds the implant stationary, as shown in FIG. 33C. In some embodiments,a rotary dial 3314 may be turned after insertion of the needle intonasal tissue but before retraction of the needle to push the implantfurther distally, e.g., to the distal end of the needle's beveledopening. A ring grip 3318 extending from the housing assists in holdingthe housing stably.

FIGS. 34A-34C show a nasal implant system 3400 according to yet anotherembodiment of the invention. The system has a housing 3404 supporting animplant holder (not shown). An implant 3402 such as, e.g., one of theimplants described with respect to FIGS. 10A-10N above, is loaded intothe implant holder, and a needle 3408 (such as, e.g., a 16 g beveledhypodermic needle) is attached to the housing over the implant viainternal threads on needle actuator 3420.

As shown in FIGS. 34A and 34B, an implant actuator 3410 extendsproximally from the housing. The implant actuator may have, e.g., a ringor cap at is distal end as shown in FIGS. 34A and 34B, respectively. Apusher 3416 extends distally from the implant actuator 3410 through thehousing to the implant holder. Distal movement of the implant actuator3410 toward the housing moves the pusher toward the implant and theimplant out of the implant holder and into the needle to place thedistal end of the implant at the beveled opening of the needle, as shownin FIG. 34C. Thereafter, proximal movement of the needle actuator 3420retracts the needle from the implant while the pusher holds the implantstationary, as shown in FIG. 34C. In some embodiments, the implantactuator may be moved further distally after insertion of the needleinto nasal tissue but before retraction of the needle to push theimplant further distally, e.g., to the distal end of the needle'sbeveled opening. Handles 3414 and 3418 extend from the housing to assistin holding the housing stably.

FIGS. 35A-35C show a nasal implant system 3500 according to stillanother embodiment of the invention. The system has a housing 3504supporting an implant holder (not shown). An implant 3502 such as, e.g.,one of the implants described with respect to FIGS. 10A-10N above, isloaded into the implant holder, and a needle 3508 (such as, e.g., a 16 gbeveled hypodermic needle) is attached to the housing over the implantvia internal threads on needle actuator 3520.

As shown in FIGS. 35A and 35B, an implant actuator 3510 extendsproximally from the housing. A pusher 3516 extends distally from theimplant actuator 3510 through the housing to the implant holder. Slidingmovement of the implant actuator 3510 within a track in the housing tothe position shown in FIG. 35C moves the pusher into and the implant outof the implant holder and into the needle to place the distal end of theimplant at the beveled opening of the needle. Thereafter, proximalmovement of the needle actuator 3520 retracts the needle from theimplant while the pusher holds the implant stationary, as shown in FIG.35C. In some embodiments, the implant actuator may be moved furtherwithin the track in the housing after insertion of the needle into nasaltissue but before retraction of the needle to push the implant furtherdistally, e.g., to the distal end of the needle's beveled opening. Aring or handle 3518 extends from the housing to assist in holding thehousing stably.

FIGS. 36A-36F show a nasal implant system 3600 according to anotherembodiment of the invention. The system has a housing 3604 supporting animplant holder (not shown) and a pistol grip 3613 having a proximalpistol grip skin 3613 and a distal trigger skin 3623. An implant 3602 isloaded into the implant holder, and a needle 3608 (such as, e.g., a 16 gbeveled hypodermic needle) is attached to the housing over the implantvia internal threads on needle actuator 3620, such as via luer 3621. Theimplant 3602 may be formed from a bio-absorbable material that mayinclude various combinations of PLA, PDLA, PDS, PLC, PGA, PLG orsimilar. As shown in FIG. 36B, implant 3602 is substantially round incross section and approximately 25 mm in length. There are convex orconcave ring features on the proximal end of the rod (spaced, e.g.,every 1 mm, 2.5 mm, or 5 mm from the end) to show the user positions tocut the rod to achieve a specific length. The implant has barbed ortined features 3631 at the distal end. These features may be made bycutting into the implant with a blade at a 30-45 degree angle, thenbending the outer portion of the implant material to its plasticdeformation point. These barbs would be flexible enough to collapseinward (i.e., into the original position prior to barb formation) whenintroduced into needle 3608 and resilient enough to expand when theimplant is released from the needle into nasal tissue. The barbs willengage the surrounding nasal tissue to prevent migration of the implantback out through its implantation path so that it maintains itstherapeutic position, e.g., overlaying the maxillary interface. Implant3602 also has proximal length markers 3627 and a proximal cup face 3625.

A plunger-shaped implant actuator 3610 extends proximally from thehousing. A pusher 3616 extends distally from the implant actuator 3610through the housing to the implant holder (through the proximal handlecore 3611). The distal face of the pusher 3616 is concave to mate withthe rounded proximal end of the implant to, e.g., center the implant onthe pusher. Distal movement of the implant actuator 3610 (such as withplunger head 3609) toward within the housing from the position shown inFIG. 36A to the position shown in FIG. 36E moves the implant out of theimplant holder and into the needle to place the distal end of theimplant at the beveled opening of the needle. Thereafter, proximalmovement of the needle actuator 3620 retracts the needle from theimplant while the pusher holds the implant stationary, as shown in FIG.36F. A handle 3618 extends from the housing to assist in holding thehousing stably.

A window 3605 in housing 3604 permits the barbs to remain extended untilthe implant is loaded into the needle. This feature enables the implantto remain in the system for an extended period of time (e.g., duringpackaging, sterilization, transportation and inventory storage) withoutan adverse effect on the position and resilience of the barbs due topolymer creep.

FIGS. 37A-37C show a nasal implant system 3700 according to yet anotherembodiment of the invention. System includes a substantially cylindricalmain body 3704, a slidable ring trigger 3710, a rod-like piercingelement 3708 extending through a tool shaft 3709, and a hollow implant3702. This nasal implant delivery tool is configured to deliver thehollow rod implant 3702 to the nasal anatomy in a similar manner to thesystems discussed above. In this embodiment, however, the piercingelement 3708 extends through the hollow implant 3702 and retains theimplant with a friction fit. The proximal end of the implant restsagainst the distal surface of the tool shaft. Once the implant andsupporting piercing element are inserted into the nasal anatomy andpositioned, e.g., against the maxilla, the entire tool (or,alternatively, the inner piercing element alone) may be retracted todeposit the implant at its target location. The implant 3702 may havebarbs, as discussed above that interact with nasal tissue to maintainthe implant in position as the delivery tool is retracted. In use, thetool and implant are inserted into nasal tissue in the configurationshown in FIG. 37A. Once in the desired location, the trigger ring 3710is retracted, as shown in FIG. 37B, thereby releasing the implant 3702.The tool shaft and piercing element are thereafter withdrawn from theimplant and the nasal tissue, as shown in FIG. 37C.

The nasal implants of this invention may be formed in larger bodies madeup of a plurality of individual implants. For example, as shown in FIG.38, a sheet 3800 is made up of multiple implants 3802 connected byoffset bridges 3804. An implant 3802 may be separated from the sheet3800 by severing the bridges connecting it to the adjacent implant 3802.The implant material may be PLA, PDLA, PDS, PLC, PGA, PLG or similarbio-absorbable material.

FIGS. 39A-39D show a delivery tool 3900 with a feature enabling it toseparate individual implants from a sheet of implants, such as the sheet3800 shown in FIG. 38. Delivery tool 3900 has a two part body, aproximal main body 3904 and a distal trigger body 3906. A opening orwindow 3908 in trigger body is size to accept a sheet 3910 formed ofmultiple implants 3912 so that the first implant segment lines up withthe inner bore of introducer needle 3914, as shown in FIGS. 39B and 39C.A cutting element 3916 has a sharp edge extending towards the implantsheet and lining up with the bridges holding the first implant on thesheet to the rest of the sheet, as shown in FIG. 39C. Distal movement ofa push rod plunger or actuator 3928 moves a push rod 3930 distally sothat sheet 3910 moves toward cutting element 3916. As it advances, thecutting element shears the bridges holding the first implant to the restof the sheet, and the implant is advanced into the bore of needle 3914,as shown in FIG. 39D. The push rod 3930 continues to advance the singleimplant 3912 to the distal end of needle 3914, as discussed inconnection with other embodiments above.

FIGS. 40A-40C show portions of another embodiment of a delivery toolwith features enabling a single implant to be cut from a sheet ofimplants. The tool may be formed similar to tool 3900 described abovewith a distal trigger housing 4009. Instead of a stationary cutting toolextending toward the sheet of implants, the pusher 4000 in theembodiment of FIG. 40 has a sharp distal edge 4002. A sheet 4002 ofindividual implants 4004 connected by bridges is advanced into thedelivery tool through a window 4006 in the tool body so that the firstimplant lines up with the bore of introducer needle 4008 (with needleinner bore 4009). Distal movement of the pusher 4000 and sharp distaledge 4002 causes the first implant to shear from the sheet and move intothe bore of needle 4008, as shown in FIG. 40C.

In yet another alternative embodiment shown in FIGS. 41A-41D with distaltrigger housing 4111, the cutting may be annular so that it both shearsthe single implant from the sheath and shaves the outer surface of thesingle implant to ensure that it fits cleanly within the bore of theneedle. The cutting tool 4102 and the pusher 4104 may be separateelements, with the annular cutting tool 4102 (such as a hypotube) beingadvanced over the pusher 4104 to perform the shearing and shavingoperations to remove implant 4108 from sheet 4012, and the pusher movingdistally to advance the implant 4106 into the needle 4110. The cuttingtool has an implant side window 4106.

In still another embodiment, illustrated in FIG. 42, the diameter of thecutting tool 4202 can be adjusted by, e.g., depressing a button 4204 onthe tool body to apply a force to a cutting tool 4202 formed as a splitcylinder. This feature enables the use of smaller implants introducedthrough smaller needles. Cutting tool 4202 has main tool body 4210. Asheet of implants 4208 is fed into the tool. Cutting tool 4202 alsoincludes delivery needle 4206.

FIGS. 43A-43E illustrates a spring-loaded implant clip. In thisembodiment, as in the embodiments above, a column of implants 4302 isloaded into the delivery tool through a window 4304. The sheet 4300 isloaded into a storage clip 4306. One or more springs 4308 and a liftplatform 4309 on one side of storage clip 4306 pushes the sheet 4300inward so that the innermost implant 4310 in the clip lines up with thebore of the introducer needle 4312. A pusher 4314 (with outer surface4324) advances implant 4310 into needle 4312, as described above. Thedelivery tool body 4322 can be hand-held and controlled by trigger 4320.

Alternatively, a sheet of implants 4311, such as that described abovewith respect to FIGS. 38-42, can be loaded into the clip 4306. In thiscase, a shearing element, such as those discussed with respect to FIGS.39-42, can be added to the assembly. The delivery tool body includes ahandle distal core 4326.

FIGS. 44A-44F illustrates yet another way of loading multiple implantsinto a delivery tool. Delivery tool 4400 has a revolvable cylindricalhousing 4402 having multiple implant chambers in which single implants4414 are disposed. Housing 4402 is rotated to a position (possiblyindicated with detents) in which an implant chamber lines up with thepusher 4406 and bore of needle 4408. The pusher 4406 then advances theimplant 4404 into the needle as described above. The delivery tool maybe hand-held by the main tool body 4410. Needle 4408 may be controlledby trigger 4412.

FIGS. 45A-45D illustrates still another embodiment in which multipleimplants may be loaded into the delivery tool and delivered separately.In this embodiment, multiple implants 4502 are connected end to end andloaded into the delivery tool parallel to the pusher 4504. A cuttingbutton 4506 in line with the distal-most implant segment in the line ofimplants can be depressed inwardly to cut one implant segment from theline and advance it into the delivery tool chamber in line with thepusher and the bore of the needle 4508. FIG. 46A is an end view and FIG.46B is a perspective view of a sheet 4600 of nasal implants 4602connected by bridges 4604. Through holes 4606 are dimensioned toreplicate Lactosorb® sheets (˜2 mm) to allow suturing. Slots 4608provide cut guides for separating individual implants.

FIG. 47A is an end view and FIG. 47B is a perspective view of a sheet4700 of nasal implants 4702 connected by bridges 4704. Through holes4706 are dimensioned to replicate Lactosorb® sheets (˜2 mm) to allowsuturing. The bridge sections are designed to break without the need tocut with a scalpel.

FIGS. 48A and 48B show a sheet 4800 of individual nasal implants 4802connected by bridges 4804. The openings 4806 in the sheet are largerthan in the embodiments of FIGS. 46 and 47 to allow for a needle andsuture to pass through.

FIG. 49A is a partial end view and FIG. 49B is a perspective view of asheet 4900 of nasal implants 4902 separated by a large sheet section4904 having holes 4906 formed therein.

FIG. 50A is a partial end view and FIG. 50B is a perspective view of asheet 5000 of nasal implants 5002 aligned in pairs. Holes 5006 areformed in bridge sections 5004 between pairs of implants.

FIG. 51A is a partial end view and FIG. 51B is a perspective view of asheet 5100 of nasal implants 5102 having rounded ends 5103. The implantsare connected by bridges 5104 having openings 5106 between them. Cuttingguide slots 5108 may be formed in the bridges.

FIGS. 52A-52H show details of a sheet 5200 of nasal implants 5202connected by bridges 5204.

EXAMPLES Example 1

Material samples testing Table 1 shows material property test results ofcandidate implants made into various shapes and sizes with the indicatedinner diameter (ID) and outer diameter OD) from the indicated materials.The modulus of elasticity (E), cross-sectional inertia of the sample(I), and flexural rigidity (E·I) which represents the strength of thesample when bending, are indicated. The PLLA and PLLA-PGA samples wereflexurally stronger than the other samples, presumably due to thestrength of the PLLA and the rod shape of the PLLA-PGA sample. ThePLLA-PDLA sample was weak in bending, presumably due to its thin-wall,tube shape. The PLLA-PCL sample was very flexible, presumably because itwas in a glassy stage as its glass transition temperature is below roomtemperature; overall it did not behave like a typical solid material.

Example 2

Table 2 shows moldability with temperature and brittleness: testingperformed on the material samples. Samples were cut to 15 mm length.Samples were tested at room temperature and heated to severaltemperatures in an oven and left to sit to ensure the materials were aconsistent temperature throughout the sample. Each sample was tested byremoving it from the oven and immediately bending it by hand to 90degrees (if possible). Observations of how much force was required,whether the material held the shape, cool off time, and materialbrittleness were recorded and summarized.

Example 3

An implantable sheet was cut and tested for fitting into a 16 gaugesyringe. Samples fit through. When a scalpel is place accurately throughthe bridge trough, the sheet could be cut relatively easily. FIG. 53Aand FIG. 53B show results from cutting an implantable sheet.

Example 4

Implant-Dimension Protocol

Results Test Methodology 20.09 mm Measured using Micro-Vu Vision System24.73 mm Measured using Micro-Vu Vision System 0.00 mm Measured heightof the implant on 0 degrees both ends Average width (mm): 1.92 Measuredand average 4 void from Average length (mm): 2.38 the sheets Rod averagelength (mm): 1.26 Measured and averaged four bridge Bridge averagelength (mm): 2.93 lengths using Micro-Vu vision system Rod groove width(mm): 0.45 Measured and averaged four bridge Bridge average width (mm):1.93 widths using Micro-Vu vision system

Example 5 Implant Flexural Rigidity Protocol

Two implant rods were soaked in water heated to 37 degrees C. for 1hour. They were then flexed from 180 degrees to 7 mm. The samples had aflexural rigidity of 114 N-mm² and 105 N-mm². Results are shown in FIGS.54A-54C.

Example 6 Implant Migration Protocol

Implant is inserted into tissue sample using cannula. Implant is placedinto test fixture and run for 1000 cycles. Implant location comparedbefore and after. Result was less than 0.5 mm vertical and horizontaltravel for all tests. The implant migration after manually flexingtissue for 5 minutes. FIGS. 55A-55B show results from a 1000 cycle testusing a test fixture. In another case, implant migration was testedafter manually flexing tissue for 5 minutes. None to minor migration wasobserved. Results are shown in FIGS. 56A-56B.

Various regions of airway tissue can impact airflow to the lungs. Onemajor impact on airflow is from airflow resistance from the nose. Thehighest resistance structures in the nose may be the narrowest regions,such as the external nasal valve 5302 and the internal nasal valve 5300,shown in FIGS. 59A-59B. During normal inspiration, nasal valve cartilagearound these valves prevents or reduces valve collapse and helpsmaintains airway patency. Incompetent internal valves and/or externalvalves can collapse and obstruct airflow during inhalation, as shown inFIGS. 60A-60B. FIG. 60A shows a valve at rest and FIG. 60B shows valvecollapse upon inhalation. Problems with the nasal septum, nasalturbinates, lateral cartilage, or other structures due to, for example,aging, poorly formed or weak cartilage, surgery (e.g., rhinoplasty,septoplasty) and/or trauma can lead to nasal valve problems and impactairflow such as difficult breathing, snoring, sleep apnea and reductionin quality of life. Provided herein are less-invasive surgicaltreatments for nasal valve collapse. Such treatments may be effective,minimally invasive, outpatient treatments and may result in reduced painand a rapid recovery, and may be a lasting solution.

Surgical treatments (e.g., submucosal resection of turbinates,septoplasty) have been used in the past to reduce the size of theturbinates or correct deviated septum or to repair the nasal wall inorder to improve the nasal valves and airflow. These surgical treatmentsare invasive, uncomfortable and require significant time to recuperate.Furthermore, they do not readily address problems with the lateralcartilage wall. The lateral cartilage wall has been repaired, forexample, by cartilaginous graft techniques using additional material(cartilage) from the nose or ear. In addition to the above mentionedlimitations, these techniques are expensive (e.g. thousands of dollars),highly invasive, require a high level of surgical experience, have long,painful recovery times (e.g. 3 weeks of downtime), do not always workwell and require a second surgical invasion site (into the nasal area orear to obtain cartilage). Invasive nasal surgery is complicated by theongoing need to use the surgical site for breathing. Thus, invasivesurgical approaches are far from ideal. Non-surgical approaches fornasal valve collapse include strips or stent-like materials (e.g.,“BreathRight”, Breathe with EEZ, Nozovent”) that are placed on or aroundthe nose. These temporary, suboptimal approaches suffer from limitedefficacy and poor cosmesis.

Provided herein are implants, assemblies, systems, and methods forimproving and repairing a nasal valve. Such valve repair materials andmethods may be used in minimally invasive procedures, outpatientprocedures and may result in minimal pain and rapid recovery, especiallycompared with previous surgical interventions.

Another aspect of the invention provides a delivery system such as shownin FIGS. 61A-61D including a delivery assembly with a delivery tool(FIG. 61A) and one or multiple nasal implants (FIGS. 61C-61D).

In some embodiments, an implant may comprise an absorbable,biocompatible polymer or copolymer such as known in the art (e.g.poly-L-lactic acid (PLLA), poly(D-lactic acid (PDLA) etc.). In aparticular embodiment, a copolymer may include both PLA and PDLA, suchas in a 70:30 PLLA/PDLA ratio. An implant may have favorablestress/strain mechanics.

An implant may be sized by a physician. An implant may comprise apolymer configured to absorb quickly or more slowly when in position ina nasal tissue. An implant may be configured to remain substantiallyintact for at least 3 months, at least 6 months, at least 9 months, orat least 12 months. An implant may be configured to be substantiallycompletely resorbed in 18 months.

An implant may be chosen to have tough but favorable stress/strainmechanics. An implant may have a strength similar to a cartilagestrength. An implant may be shapeable without fracturing. An implant maya flexure similar to a flexure of cartilage. An implant may beconfigured to have a flexural rigidity stronger than cartilage when inplace in a nasal tissue for longer than 6 months.

An implant may be any size that provides a therapeutic or cosmeticbenefit and/or facilitates implantation or bioabsorption. An implant maybe sized to fit into a needle, such as an off-the-shelf needle (e.g.larger than 10 gauge, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32 gauge, or smaller than 32gauge). An implant may be held in a needle by any means, such as a tight(friction fit), a tab, a mating mechanism, etc. An implant may havefeatures (e.g. ridges, bumps, etc.) and may contact an internal surfaceof a needle when in place in a delivery assembly.

An implant may be any shape that provides a therapeutic or cosmeticbenefit and/or facilitates implantation or bioabsorption. An implant mayhave one or more substantially flat side(s) and ribs that allow for amaximized rod diameter and rib height without excessive friction when inplace in a needle. A ribbed configuration may eliminate implantmigration.

Another aspect of the invention provides a plurality of interconnectedimplants such as shown in FIGS. 62A-62D. FIGS. 62A-62B show rod implantsand FIG. 62C shows a detail view of the section “A” indicated in FIG.62B. Two or more than two implants may be formed as a long structure.Two or more than two implants may be molded together, such as injectionmolded in a perforated sheet. Implants may be separated, such as with acutting instrument. An implant, such as those shown in FIGS. 62A-62D mayhave an anti-migration feature. For example, an implant with ananti-migration feature may have an increase (e.g., 5X) in acutelongitudinal stability relative to a smooth implant. An implant with ananti-migration feature may be easier to injection mold. Such an implantmay have predictable degradation. An implant may represent nasalcartilage mechanics. An implant may have a flexural rigidity valuestronger than cartilage for a time period (e.g., 6 months) after beingimplanted. An implant may be shapeable without fracturing. An implantmay have an average acute flexibility similar to reconstruction plateproducts. An implant may have flat sides to allow for maximized roddiameter and rib height without excessive friction in needle bore.

Another aspect of the invention provides a delivery tool assemblyconfigured to delivery an implant into a nasal tissue. A delivery toolassembly may include a needle configured to house an implant and astylus configured to push an implant out of the needle and into nasaltissue during implant delivery (such as to a nasal valve region).

A delivery tool assembly may include an implant positioning knobconfigured to move an implant to a desired (distal) staging area. Adistal staging area may be near or at a tip of a needle.

A delivery tool assembly may include a trigger lock mechanism to preventundesired needle movement.

A needle of a delivery tool assembly may be configured to pierce a nasalmucosa and position an implant in a desired location in a nasal tissue.An implant may be configured to be pushed out of a needle at the sametime that a needle is removed from the tissue. In some cases,simultaneous pushing of an implant from a needle and removal of a needlefrom nasal tissue may result in undesired implant movement or implantrepositioning.

In some embodiments, a delivery tool may be configured to be held in ahand (e.g. may have an ergonomic design) as shown in FIGS. 63A-63C. Adelivery device may be designed to pierce mucosa and position an implantin a desired position.

In some embodiments, a delivery tool may have a needle advance position(FIG. 64A) and a needle retracted position (FIG. 64B). A delivery toolmay have a body, a grip (e.g. a half-grip 5316), a trigger, a triggerlock 5314, a needle 5318, an implant positioning knob 5312, and animplant plunger 5320 or stylus such as shown in FIGS. 64A-64B. Anover-under trigger 5310 mechanism configured to provide axial stabilityduring needle placement, implant placement, and/or needle retraction.The implant positioning knob 5312 advances the implant to the distalstaging area at the needle tip. The needle (e.g., a 16 gauge hypodermicneedle) may make a small entry site with minimal tissue dissection andpain. The implant plunger 5320 injects the implant. It may have afront-end “bone prep” feature (e.g., a drill bit). A trigger lock 5314may provide safety during needle placement. A half-grip may maintain alow profile grip arm.

A delivery tool assembly may comprise multiple implants. Multipleimplants may be loaded at one time. Alternatively, an implant may beloaded, implanted, and the delivery tool assembly reloaded with anotherimplant for delivery.

A delivery tool assembly may include a bone prep feature (e.g. a drillbit).

Tactile clues may be used for placing an implant in a nasal tissue. Onesuch tactile clue may include palpating a nasal region (e.g. palpatingan implant or a needle from an outside surface of the nose). Anothersuch tactile clue may include sensing a resistance from a delivery toolassembly in place in a nasal tissue wherein the resistance is indicativeof the delivery tool assembly contacting a bone.

One method of placing an implant in a nasal valve includes the steps ofplacing a delivery tool assembly in contact with a nasal tissue, thedelivery tool assembly comprising a needle housing an implant, advancingthe needle and implant into a nasal tissue until the needle contacts abone, releasing a needle safety lock on the delivery tool assembly, andunsheathing the implant by retracting the needle proximally to therebyplace the implant adjacent the bone. For example, the implant remains ina desired position while the needle is retracted away from the implant.

In some embodiments, an implant is placed in a nasal tissue such thatmost or all of the implant is surrounded by nasal tissue and/or tissueoverlying the maxilla. Nasal tissue may form a support, such as a tightsupport, around the implant.

FIG. 65 shows implants 5330 placed in a lateral wall of a nasal valve,such as to strengthen the valve. One, two, or more than two implants maybe placed. The implants may be parallel to each other or may beobliquely oriented relative to one another. An implant may be placed toendonasally pierce through mucosa, may be lateral to mucosa, medial tolateral cartilage and/or superficial to the maxilla.

FIGS. 66A-66C show implants 5340 placed in a “spreader” region, such asalong a superior aspect of the nose. Such an implant may endonasallypierce through mucosa, wedge between the lateral cartilage and theseptum, and/or increase an internal nasal angle.

FIGS. 67A-67C show one embodiment of a method for placing one or moreimplants in nasal tissue. Any number of implants may be placed and inany orientation. Implants may be placed almost parallel to a bottomplane of the nose (e.g. as shown in FIG. 67C). Implants may be obliquerelative to a bottom plane of the nose. For example, an implant may forma line from a tip of the nose to a corner of the eye. In someembodiments, an implant 5350 may be sized by a physician to anappropriate length and inserted into a delivery device as shown in FIG.67A. As shown in FIG. 67B, the delivery device is inserted below lateralcartilage and advanced to the maxilla bone. An implant is pushed out ofthe delivery device, creating a support beam between lateral cartilageand maxilla. A plurality of implants 5352 may be placed. As shown inFIG. 67C, the delivery device is removed, leaving the implant as asupport beam to prevent nasal valve collapse.

FIGS. 68A-68D show steps in preparing and implanting an implant in anose. FIG. 68A shows forming an implant. FIG. 68B shows implant deliverypreparation. FIGS. 68C-68D show, respectively, internal and externalviews of implant delivery.

FIG. 69 shows subjective interpretation of nasal obstruction symptomsafter implanting implants in a pilot study after 6 months and 12 months,compared with pre-implantation symptoms using a validated NOSE (NasalObstruction Symptom Evaluation) scale. Nasal obstruction was reduced.

1. (canceled)
 2. A nasal implant comprising: a first end comprising aplurality of tines, wherein the plurality of tines are resilientlydeformable between a contracted shape and an expanded shape; a secondend comprising a second-end shape that is different than the contractedshape of the plurality of tines and the expanded shape of the pluralityof tines; and an elongate body extending between the first end and thesecond end, wherein, when the plurality of tines are in the contractedshape, the plurality of tines define a non-circular shape, and wherein,when the plurality of tines are in the expanded shape, respective endsof the plurality of tines protrude outwardly from the first end suchthat plurality of tines are configured to anchor the nasal implant tonasal tissue when the nasal implant is in the nasal tissue.
 3. The nasalimplant of claim 2, wherein the second-end shape is a rounded end shape.4. The nasal implant of claim 3, wherein the rounded end shape issemi-elliptical.
 5. The nasal implant of claim 2, wherein the pluralityof tines point from away from the second end of the nasal implant. 6.The nasal implant of claim 2, wherein the plurality of tines consist oftwo tines.
 7. The nasal implant of claim 6, wherein respective ends ofthe two tines are separated by a first distance when the plurality oftines are in the contracted shape, wherein the respective ends of thetwo tines are separated by a second distance when the plurality of tinesare in the expanded shape, and wherein the second distance is greaterthan the first distance.
 8. The nasal implant of claim 2, wherein theelongated body comprises a plurality of repeating features along alength of the nasal implant between the first end and the second end. 9.The nasal implant of claim 8, wherein the plurality of repeatingfeatures comprise a plurality of ribs defined by a plurality ofalternating raised regions and depressed regions.
 10. The nasal implantof claim 2, wherein the first end, the second end, and the elongate bodycomprise a material that is biodegradable and biocompatible.
 11. Thenasal implant of claim 10, wherein the material is poly-L-lactic acid(PLLA).
 12. The nasal implant of claim 10, wherein the material ispoly-D-lactic acid (PDLA).
 13. The nasal implant of claim 2, wherein,when the plurality of tines are in the contracted shape, the nasalimplant has an outer diameter less than 1.5 millimeters (mm).
 14. Thenasal implant of claim 2, wherein the nasal implant is configured toprovide an implant flexural rigidity between 2.5 e-6 and 1.5 e-5. 15.The nasal implant of claim 2, wherein a length of the nasal implantbetween the first end and the second end is less than 30 mm.
 16. Thenasal implant of claim 2, wherein a length of the nasal implant betweenthe first end and the second end is less than 25 mm.
 17. A method ofimplanting a nasal implant into a nasal tissue of a patient, comprising:providing a nasal implant in a delivery conduit of a delivery device,wherein the nasal implant comprises: a first end comprising a pluralityof tines, wherein the plurality of tines are resiliently deformablebetween a contracted shape and an expanded shape, a second endcomprising a second-end shape that is different than the contractedshape of the plurality of tines and the expanded shape of the pluralityof tines, and an elongate body extending between the first end and thesecond end, wherein, when the plurality of tines are in the contractedshape, the plurality of tines define a non-circular shape, and wherein,when the plurality of tines are in the expanded shape, respective endsof the plurality of tines protrude outwardly from the first end suchthat plurality of tines are configured to anchor the nasal implant tonasal tissue when the nasal implant is in the nasal tissue; andimplanting, using the delivery device, the nasal implant in nasaltissue.
 18. The method of claim 17, wherein implanting the nasal implantin the nasal tissue comprises: piercing the nasal tissue with a piercingend of the delivery conduit by moving the delivery conduit through thenasal tissue; advancing the nasal implant out of the delivery conduit tothereby expand the implant to the expanded shape and anchor theplurality of tines of the nasal implant to the nasal tissue; andremoving the delivery conduit from the nasal tissue.
 19. The method ofclaim 18, wherein the delivery device comprises an interior orientingportion having a cross-sectional shape configured to orient the nasalimplant relative to the delivery conduit such that the first end thenasal implant is nearer to the piercing end of the delivery conduit thanthe second end of the nasal implant, and wherein providing the nasalimplant in the delivery conduit comprises loading the nasal implant viathe interior orienting portion.
 20. The method of claim 17, whereinproviding the nasal implant in the delivery conduit comprises loadingthe nasal implant in the delivery conduit such that the nasal implant isin the contracted shape.
 21. The method of claim 20, further comprising:releasing a user-controlled safety mechanism to thereby allow movementof the nasal implant relative to the delivery conduit; and actuating anactuation mechanism to advance the nasal implant out of the deliveryconduit.